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    Clinical Trial Results:
    Effect of Duloxetine 30/60 mg Once Daily versus Placebo in Adolescents with Juvenile Primary Fibromyalgia Syndrome

    Summary
    EudraCT number
    		 2018-001615-78
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Jun 2018
    First version publication date
    10 Jun 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    14099
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01237587
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Eli Lilly and Company: 14099
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Nov 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine whether duloxetine is safe and effective in the treatment of adolescents with Juvenile Primary Fibromyalgia Syndrome (JPFS). This trial consists of two distinct study periods. A blinded treatment period of 13 weeks and an open label extension period of 26 weeks.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Mar 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 128
    Country: Number of subjects enrolled
    Puerto Rico: 5
    Country: Number of subjects enrolled
    Argentina: 38
    Country: Number of subjects enrolled
    India: 13
    Worldwide total number of subjects
    184
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    184
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 13 week Double-Blind Treatment Phase (Acute Phase), followed by 26 week Open-Label Extension Treatment Phase (Extension Phase), followed by 1 week Taper/Discontinuation Phase.

    Pre-assignment
    Screening details
    		 Subjects were evaluated by the investigator to determine if they meet the diagnostic criteria for JPFS, based upon Yunus and Masi’s criteria. subjects had undergone a physical examination and multiple screening procedures that need to be assessed prior to initiating a “washout period” for any excluded medications.

    Period 1
    Period 1 title
    Double blind treatment (Acute Phase)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Duloxetine
    Arm description
    		 Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Duloxetine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 30 or 60 mg flexible doses of duloxetine capsules orally once daily.

    Arm title
    		 Placebo
    Arm description
    		 Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received placebo capsules orally once daily.

    Number of subjects in period 1
    		Duloxetine Placebo
    Started
    91
    93
    Received at least one dose of study drug
    91
    93
    Completed
    74
    75
    Not completed
    17
    18
         Parent/Caregiver Decision
    2
    4
         Consent withdrawn by subject
    3
    4
         Adverse event, non-fatal
    5
    1
         Lost to follow-up
    2
    3
         Lack of efficacy
    1
    3
         Protocol deviation
    4
    3
    Period 2
    Period 2 title
    Open Label Treatment (Extension Phase)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Duloxetine/Duloxetine
    Arm description
    		 Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Duloxetine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 30 or 60 mg flexible doses of duloxetine capsules orally once daily.

    Arm title
    		 Placebo/Duloxetine
    Arm description
    		 Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Duloxetine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 30 or 60 mg flexible doses of duloxetine capsules orally once daily.

    Number of subjects in period 2
    		Duloxetine/Duloxetine Placebo/Duloxetine
    Started
    74
    75
    Received at least one dose of study drug
    74
    75
    Completed
    56
    50
    Not completed
    18
    25
         Physician decision
    4
    4
         Consent withdrawn by subject
    -
    5
         Adverse event, non-fatal
    5
    5
         Parent/Guardian Decision
    2
    4
         Sponsor Decision
    1
    -
         Lost to follow-up
    4
    3
         Lack of efficacy
    2
    4
    Period 3
    Period 3 title
    Taper Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Duloxetine/Duloxetine
    Arm description
    		 Participants who received higher doses of Duloxetine in acute & extension phase received gradually lower doses of duloxetine & participants on lower doses of Duloxetine in acute phase received placebo during 1-week tapering phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Duloxetine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 30 mg duloxetine capsules orally once daily.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received placebo capsules orally once daily.

    Arm title
    		 Placebo/Duloxetine
    Arm description
    		 Participants who received placebo in acute phase received placebo & participants who received higher doses of Duloxetine in extension phase received gradually lower doses of duloxetine during1-week tapering phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Duloxetine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 30 mg duloxetine capsules orally once daily.

    Investigational medicinal product name
    Duloxetine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 30 mg duloxetine capsules orally once daily.

    Number of subjects in period 3 [1]
    		Duloxetine/Duloxetine Placebo/Duloxetine
    Started
    36
    44
    Completed
    31
    34
    Not completed
    5
    10
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    -
    2
         Parent/Guardian Decision
    -
    2
         Sponsor Decision
    1
    -
         Protocol deviation
    2
    -
         Lack of efficacy
    2
    5
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Participants who discontinued Acute or Extension phase had an option to enter tapering phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Duloxetine
    Reporting group description
    		 Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase.

    Reporting group values
    		 Duloxetine Placebo Total
    Number of subjects
    		 91 93 184
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 91 93 184
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 15.74 ± 1.379 15.33 ± 1.421 -
    Gender categorical
    Units: Subjects
        Female
    		 73 65 138
        Male
    		 18 28 46
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 36 39 75
        Not Hispanic or Latino
    		 54 54 108
        Unknown or Not Reported
    		 1 0 1
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 1
        Asian
    		 6 7 13
        Native Hawaiian or Other Pacific Islander
    		 0 1 1
        Black or African American
    		 7 8 15
        White
    		 72 70 142
        More than one race
    		 4 6 10
        Unknown or Not Reported
    		 1 1 2
    Region of Enrollment
    Units: Subjects
        Puerto Rico
    		 2 3 5
        Argentina
    		 19 19 38
        United States
    		 64 64 128
        India
    		 6 7 13
    Brief Pain Inventory (BPI) Modified short form (SF) Adolescent version (AV) Average Pain
    BPI Modified SF AV is a scale that measures severity & interference of pain. Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). 4 questions assessing severity for worst pain, least pain, average pain in past 24 hours, & pain right now.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 ± ± -
    Subject analysis sets

    Subject analysis set title
    Duloxetine - Acute
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks.

    Subject analysis set title
    Placebo - Acute
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received Placebo orally once daily (QD) for 13 weeks.

    Subject analysis set title
    Duloxetine/Duloxetine - Extension Phase
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).

    Subject analysis set title
    Placebo/Duloxetine - Extension Phase
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).

    Subject analysis set title
    Duloxetine - Acute
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks.

    Subject analysis set title
    Placebo - Acute
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received Placebo orally once daily (QD) for 13 weeks.

    Subject analysis sets values
    		 Duloxetine - Acute Placebo - Acute Duloxetine/Duloxetine - Extension Phase Placebo/Duloxetine - Extension Phase Duloxetine - Acute Placebo - Acute
    Number of subjects
    76
    76
    74
    75
    90
    91
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
        Male
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
        Not Hispanic or Latino
        Unknown or Not Reported
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
        Asian
        Native Hawaiian or Other Pacific Islander
        Black or African American
        White
        More than one race
        Unknown or Not Reported
    Region of Enrollment
    Units: Subjects
        Puerto Rico
        Argentina
        United States
        India
    Brief Pain Inventory (BPI) Modified short form (SF) Adolescent version (AV) Average Pain
    BPI Modified SF AV is a scale that measures severity & interference of pain. Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). 4 questions assessing severity for worst pain, least pain, average pain in past 24 hours, & pain right now.
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    5.7 ± 1.37
    5.6 ± 1.55

    End points

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    End points reporting groups
    Reporting group title
    Duloxetine
    Reporting group description
    		 Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase.
    Reporting group title
    Duloxetine/Duloxetine
    Reporting group description
    		 Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).

    Reporting group title
    Placebo/Duloxetine
    Reporting group description
    		 Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).
    Reporting group title
    Duloxetine/Duloxetine
    Reporting group description
    		 Participants who received higher doses of Duloxetine in acute & extension phase received gradually lower doses of duloxetine & participants on lower doses of Duloxetine in acute phase received placebo during 1-week tapering phase.

    Reporting group title
    Placebo/Duloxetine
    Reporting group description
    		 Participants who received placebo in acute phase received placebo & participants who received higher doses of Duloxetine in extension phase received gradually lower doses of duloxetine during1-week tapering phase.

    Subject analysis set title
    Duloxetine - Acute
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks.

    Subject analysis set title
    Placebo - Acute
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received Placebo orally once daily (QD) for 13 weeks.

    Subject analysis set title
    Duloxetine/Duloxetine - Extension Phase
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 13 weeks during double blind treatment period (Acute Phase) and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).

    Subject analysis set title
    Placebo/Duloxetine - Extension Phase
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received Placebo orally once daily (QD) for 13 weeks during double blind treatment phase and flexible doses of 30 or 60 milligram (mg) Duloxetine orally once daily (QD) for 26 weeks during open label extension treatment period (Extension Phase).

    Subject analysis set title
    Duloxetine - Acute
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received 30 or 60 mg Duloxetine orally once daily (QD) for 13 weeks.

    Subject analysis set title
    Placebo - Acute
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received Placebo orally once daily (QD) for 13 weeks.

    Primary: Change from baseline to 13 week endpoint in Brief Pain Inventory (BPI) modified short form-adolescent version 24 hour average pain severity item

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    End point title
    		 Change from baseline to 13 week endpoint in Brief Pain Inventory (BPI) modified short form-adolescent version 24 hour average pain severity item
    End point description
    Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours. Mixed Model Repeated Measure (MMRM) model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce Least Square (LS) means. Analysis Population Description (APD): All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI average pain score.
    End point type
    Primary
    End point timeframe
    Baseline, 13 weeks
    End point values
    		 Duloxetine - Acute Placebo - Acute
    Number of subjects analysed
    76
    76
    Units: units on a scale
        least squares mean (standard error)
    -1.62 ± 0.247
    -0.97 ± 0.244
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.052
    Method
    		 Repeated Measures
    Parameter type
    		 LS mean change difference
    Point estimate
    -0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.33

    Secondary: Change from baseline to 13 week endpoint in Brief Pain Inventory (BPI) modified short form-Adolescent version severity and interference items

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    End point title
    		 Change from baseline to 13 week endpoint in Brief Pain Inventory (BPI) modified short form-Adolescent version severity and interference items
    End point description
    The Brief Pain Inventory (BPI) - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work. MMRM model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce LS means.
    End point type
    Secondary
    End point timeframe
    Baseline, 13 weeks APD:Analysis population description: All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI severity & interferences items score.
    End point values
    		 Duloxetine - Acute Placebo - Acute
    Number of subjects analysed
    76
    76
    Units: units on a scale
    least squares mean (standard error)
        Worst Pain
    -1.58 ± 0.270
    -0.90 ± 0.266
        Least Pain
    -1.08 ± 0.239
    -0.47 ± 0.236
        Pain Right Now
    -1.56 ± 0.274
    -1.05 ± 0.271
        General Activity
    -2.00 ± 0.262
    -1.03 ± 0.258
        Mood
    -2.00 ± 0.269
    -1.46 ± 0.265
        Walking ability
    -1.30 ± 0.266
    -1.09 ± 0.262
        Normal Work
    -1.49 ± 0.277
    -1.21 ± 0.274
        Relations With Other People
    -1.87 ± 0.237
    -1.07 ± 0.233
        Sleep
    -1.40 ± 0.343
    -1.05 ± 0.338
        Enjoyment of Life
    -1.76 ± 0.253
    -1.47 ± 0.250
        School Work
    -1.68 ± 0.316
    -1.08 ± 0.313
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Worst Pain
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.059
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 0.03
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.36
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Least Pain
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.059
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.24
         upper limit
    		 0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.319
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Pain Right Now
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.165
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.23
         upper limit
    		 0.21
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.365
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    General Activity
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.65
         upper limit
    		 -0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.344
    Statistical analysis title
    		 Statistical Analysis 5
    Statistical analysis description
    Mood
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.128
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.25
         upper limit
    		 0.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.356
    Statistical analysis title
    		 Statistical Analysis 6
    Statistical analysis description
    Walking ability
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.56
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.9
         upper limit
    		 0.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.352
    Statistical analysis title
    		 Statistical Analysis 7
    Statistical analysis description
    Normal Work
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.448
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.01
         upper limit
    		 0.45
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.371
    Statistical analysis title
    		 Statistical Analysis 8
    Statistical analysis description
    Relations With Other
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.011
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.42
         upper limit
    		 -0.19
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.312
    Statistical analysis title
    		 Statistical Analysis 9
    Statistical analysis description
    Sleep
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.443
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.25
         upper limit
    		 0.55
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.454
    Statistical analysis title
    		 Statistical Analysis 10
    Statistical analysis description
    Enjoyment of Life
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.39
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.96
         upper limit
    		 0.38
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.338
    Statistical analysis title
    		 Statistical Analysis 11
    Statistical analysis description
    School Work
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.16
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.44
         upper limit
    		 0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.424

    Secondary: Maintenance effect in acute phase responders on the Brief Pain Inventory (BPI) modified short form-adolescent version 24 hour average pain severity item

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    End point title
    		 Maintenance effect in acute phase responders on the Brief Pain Inventory (BPI) modified short form-adolescent version 24 hour average pain severity item
    End point description
    Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function.Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours. Acute phase responders: Participants with ≥30% pain reduction from baseline on the BPI average pain severity measure at the last non-missing assessment in acute phase. APD:All randomized participants in duloxetine only arm with ≥30% pain reduction from baseline on the BPI average pain severity measure at the last non-missing assessment in acute phase.
    End point type
    Secondary
    End point timeframe
    Baseline (Extension Phase), 39 weeks
    End point values
    		 Duloxetine/Duloxetine - Extension Phase
    Number of subjects analysed
    44
    Units: units on a scale
        arithmetic mean (standard deviation)
    -3.4 ± 1.24
    No statistical analyses for this end point

    Secondary: Number of participants with greater than or equal to 30% reduction from baseline in BPI 24 hour average pain severity score at 13 weeks

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    End point title
    		 Number of participants with greater than or equal to 30% reduction from baseline in BPI 24 hour average pain severity score at 13 weeks
    End point description
    Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours. Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF). APD:All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI average pain score.
    End point type
    Secondary
    End point timeframe
    13 weeks
    End point values
    		 Duloxetine - Acute Placebo - Acute
    Number of subjects analysed
    90
    91
    Units: Participants
        number (not applicable)
    47
    33
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.051
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Number of participants with greater than or equal to 50% reduction from baseline in BPI 24 hour average pain severity score at 13 weeks

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    End point title
    		 Number of participants with greater than or equal to 50% reduction from baseline in BPI 24 hour average pain severity score at 13 weeks
    End point description
    Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours. Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF). APD:All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline BPI average pain score.
    End point type
    Secondary
    End point timeframe
    13 weeks
    End point values
    		 Duloxetine - Acute Placebo - Acute
    Number of subjects analysed
    90
    91
    Units: Participants
        number (not applicable)
    36
    22
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.038
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Change from baseline in Pediatric Pain Questionnaire (PPQ) item scores

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    End point title
    		 Change from baseline in Pediatric Pain Questionnaire (PPQ) item scores
    End point description
    Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for “pain now,” worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain). Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value. APD:All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline PPQ score.
    End point type
    Secondary
    End point timeframe
    Baseline, 13 weeks
    End point values
    		 Duloxetine - Acute Placebo - Acute
    Number of subjects analysed
    87
    86
    Units: mm
    least squares mean (standard error)
        Average Pain Score
    -11.03 ± 2.982
    -9.41 ± 2.946
        Worst Pain Score
    -14.36 ± 3.367
    -8.46 ± 3.322
        Pain Score Right Now
    -8.99 ± 3.092
    -7.20 ± 3.065
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Average Pain Score
    Comparison groups
    Placebo - Acute v Duloxetine - Acute
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.669
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.1
         upper limit
    		 5.86
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Worst Pain Score
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.169
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.32
         upper limit
    		 2.53
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Pain Score Right Now
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.647
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.53
         upper limit
    		 5.94

    Secondary: Change from baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score

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    End point title
    		 Change from baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score
    End point description
    Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value. APD:All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline CGI-S overall illness score.
    End point type
    Secondary
    End point timeframe
    Baseline, 13 weeks
    End point values
    		 Duloxetine - Acute Placebo - Acute
    Number of subjects analysed
    90
    92
    Units: units on a scale
        least squares mean (standard error)
    -0.88 ± 0.121
    -0.66 ± 0.118
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.146
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.52
         upper limit
    		 0.08

    Secondary: Change from baseline in Clinical Global Impression (CGI) Severity: Mental illness score

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    End point title
    		 Change from baseline in Clinical Global Impression (CGI) Severity: Mental illness score
    End point description
    Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill). Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value. APD:All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline CGI-S mental illness score.
    End point type
    Secondary
    End point timeframe
    Baseline, 13 weeks
    End point values
    		 Duloxetine - Acute Placebo - Acute
    Number of subjects analysed
    90
    92
    Units: units on a scale
        least squares mean (standard error)
    -0.16 ± 0.089
    -0.15 ± 0.087
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.927
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.23
         upper limit
    		 0.21

    Secondary: Change From Baseline in Functional Disability Inventory Child Form (FDI-Child)

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    End point title
    		 Change From Baseline in Functional Disability Inventory Child Form (FDI-Child)
    End point description
    Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value. APD:All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline FDI child scale score.
    End point type
    Secondary
    End point timeframe
    Baseline, 13 weeks
    End point values
    		 Duloxetine - Acute Placebo - Acute
    Number of subjects analysed
    87
    88
    Units: units on a scale
        least squares mean (standard error)
    -3.97 ± 1.038
    -5.00 ± 1.021
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    175
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.431
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.54
         upper limit
    		 3.59

    Secondary: Change From Baseline in Functional Disability Inventory Parent Form (FDI-Parent)

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    End point title
    		 Change From Baseline in Functional Disability Inventory Parent Form (FDI-Parent)
    End point description
    Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value. APD:All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline FDI-parent scale score.
    End point type
    Secondary
    End point timeframe
    Baseline, 13 weeks
    End point values
    		 Duloxetine - Acute Placebo - Acute
    Number of subjects analysed
    86
    87
    Units: units on a scale
        least squares mean (standard error)
    -3.25 ± 1.152
    -4.17 ± 1.139
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.529
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.95
         upper limit
    		 3.79

    Secondary: Change from baseline in Children's Depression Inventory (CDI)

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    End point title
    		 Change from baseline in Children's Depression Inventory (CDI)
    End point description
    Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value. APD:All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline CDI score.
    End point type
    Secondary
    End point timeframe
    Baseline, 13 weeks
    End point values
    		 Duloxetine - Acute Placebo - Acute
    Number of subjects analysed
    89
    89
    Units: units on a scale
        least squares mean (standard error)
    -3.28 ± 0.682
    -2.45 ± 0.674
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.335
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.52
         upper limit
    		 0.86

    Secondary: Change from baseline in Multidimensional Anxiety Scale for Children (MASC)

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    End point title
    		 Change from baseline in Multidimensional Anxiety Scale for Children (MASC)
    End point description
    Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents.The MASC consists of 39 items that comprise 4 factors, 3 of which can be separated into 2 sub factors each. Main factors (sub factors) include: 1) physical symptoms (tense/restless and somatic/autonomic); 2) social anxiety (humiliation/rejection and public performance fears); 3) harm avoidance (perfectionism and anxious coping); and 4) separation anxiety. Each item is scored on a 0-to-3-point scale (0–never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). Total score range from 0 to 117. The higher the total score, the more severe the anxiety. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline, 13 weeks APD:Analysis population description: All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline MASC score.
    End point values
    		 Duloxetine - Acute Placebo - Acute
    Number of subjects analysed
    89
    89
    Units: units on a scale
    least squares mean (standard error)
        Physical Symptoms
    -1.39 ± 0.663
    -1.44 ± 0.652
        Harm Avoidance
    -1.34 ± 0.507
    -0.78 ± 0.501
        Social Anxiety
    -1.86 ± 0.497
    -1.42 ± 0.489
        Separation/Panic
    -1.62 ± 0.393
    -1.43 ± 0.389
        Total Score
    -6.21 ± 1.575
    -4.99 ± 1.558
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Physical Symptoms Score
    Comparison groups
    Placebo - Acute v Duloxetine - Acute
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.955
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.59
         upper limit
    		 1.68
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Harm Avoidance
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.381
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.82
         upper limit
    		 0.7
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Social Anxiety
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.486
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.66
         upper limit
    		 0.79
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Separation/Panic
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.17
         upper limit
    		 0.79
    Statistical analysis title
    		 Statistical Analysis 5
    Statistical analysis description
    Total Score
    Comparison groups
    Duloxetine - Acute v Placebo - Acute
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.54
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.12
         upper limit
    		 2.69

    Secondary: Change From Baseline to 39 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version Severity and Interference Items

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    End point title
    		 Change From Baseline to 39 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version Severity and Interference Items
    End point description
    BPI - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain & interference of pain on function. Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, & enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
    End point type
    Secondary
    End point timeframe
    Baseline (extension phase), 39 weeks APD:Analysis population description: All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline BPI severity & interferences items scores.
    End point values
    		 Duloxetine/Duloxetine - Extension Phase Placebo/Duloxetine - Extension Phase
    Number of subjects analysed
    74
    75
    Units: units on a scale
    least squares mean (standard error)
        Worst Pain
    -0.65 ± 0.262
    -0.80 ± 0.256
        Least Pain
    -0.29 ± 0.218
    -0.45 ± 0.212
        Pain Right Now
    -0.38 ± 0.259
    -0.29 ± 0.252
        General Activity
    -0.18 ± 0.233
    0.20 ± 0.229
        Mood
    -0.15 ± 0.270
    -0.25 ± 0.258
        Walking Ability
    -0.24 ± 0.260
    -0.21 ± 0.253
        Normal Work
    -0.62 ± 0.231
    -0.32 ± 0.226
        Relations with Other People
    -0.12 ± 0.229
    -0.41 ± 0.222
        Sleep
    -0.63 ± 0.292
    -0.54 ± 0.284
        Enjoyment of Life
    -0.25 ± 0.243
    -0.26 ± 0.236
        School Work
    -0.59 ± 0.278
    -0.06 ± 0.271
    No statistical analyses for this end point

    Secondary: Change from baseline in Pediatric Pain Questionnaire (PPQ) item scores

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    End point title
    		 Change from baseline in Pediatric Pain Questionnaire (PPQ) item scores
    End point description
    Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for "pain now," worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain). Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. APD:All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline PPQ measurement. Baseline for extension phase is defined as the last non-missing value in acute phase.
    End point type
    Secondary
    End point timeframe
    Baseline (extension phase), 39 weeks
    End point values
    		 Duloxetine/Duloxetine - Extension Phase Placebo/Duloxetine - Extension Phase
    Number of subjects analysed
    68
    60
    Units: units on a scale
    least squares mean (standard error)
        Average Pain Score
    -10.65 ± 3.080
    -6.44 ± 3.296
        Worst Pain Score
    -4.15 ± 3.127
    -8.06 ± 3.677
        Score Right Now
    -4.74 ± 3.075
    -6.34 ± 3.335
    No statistical analyses for this end point

    Secondary: Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score

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    End point title
    		 Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score
    End point description
    Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value. APD:All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline CGI overall illness measurement. Baseline for extension phase is defined as the last non-missing value in acute phase.
    End point type
    Secondary
    End point timeframe
    Baseline (extension phase), 39 weeks
    End point values
    		 Duloxetine/Duloxetine - Extension Phase Placebo/Duloxetine - Extension Phase
    Number of subjects analysed
    74
    75
    Units: units on a scale
        least squares mean (standard error)
    -0.67 ± 0.125
    -0.67 ± 0.121
    No statistical analyses for this end point

    Secondary: Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score

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    End point title
    		 Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score
    End point description
    Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill). Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value. APD:All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline CGI mental Illness measurement. Baseline for extension phase is defined as the last non-missing value in acute phase.
    End point type
    Secondary
    End point timeframe
    Baseline (extension phase), 39 weeks
    End point values
    		 Duloxetine/Duloxetine - Extension Phase Placebo/Duloxetine - Extension Phase
    Number of subjects analysed
    74
    75
    Units: units on a scale
        least squares mean (standard error)
    -0.20 ± 0.104
    -0.24 ± 0.101
    No statistical analyses for this end point

    Secondary: Change From Baseline in Functional Disability Inventory Child Form (FDI-child)

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    End point title
    		 Change From Baseline in Functional Disability Inventory Child Form (FDI-child)
    End point description
    Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. APD:All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline FDI-child measurement. Baseline for extension phase is defined as the last non-missing value in acute phase.
    End point type
    Secondary
    End point timeframe
    Baseline (extension phase), 39 weeks
    End point values
    		 Duloxetine/Duloxetine - Extension Phase Placebo/Duloxetine - Extension Phase
    Number of subjects analysed
    68
    60
    Units: units on a scale
        least squares mean (standard error)
    -3.49 ± 1.227
    -2.27 ± 1.327
    No statistical analyses for this end point

    Secondary: Change From Baseline in Functional Disability Inventory Parent Form (FDI-parent)

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    End point title
    		 Change From Baseline in Functional Disability Inventory Parent Form (FDI-parent)
    End point description
    Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. APD:All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline FDI-parent measurement. Baseline for extension phase is defined as the last non-missing value in acute phase.
    End point type
    Secondary
    End point timeframe
    Baseline (extension phase), 39 weeks
    End point values
    		 Duloxetine/Duloxetine - Extension Phase Placebo/Duloxetine - Extension Phase
    Number of subjects analysed
    68
    60
    Units: units on a scale
        least squares mean (standard error)
    -3.49 ± 1.227
    -2.27 ± 1.327
    No statistical analyses for this end point

    Secondary: Change From Baseline in Children's Depression Inventory (CDI)

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    End point title
    		 Change From Baseline in Children's Depression Inventory (CDI)
    End point description
    Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. APD:All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline CDI measurement. Baseline for extension phase is defined as the last non-missing value in acute phase.
    End point type
    Secondary
    End point timeframe
    Baseline (extension phase), 39 weeks
    End point values
    		 Duloxetine/Duloxetine - Extension Phase Placebo/Duloxetine - Extension Phase
    Number of subjects analysed
    74
    74
    Units: units on a scale
        least squares mean (standard error)
    -0.42 ± 0.703
    -1.41 ± 0.681
    No statistical analyses for this end point

    Secondary: Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)

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    End point title
    		 Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)
    End point description
    Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors, 3 of which can be separated into 2 sub factors each. Main factors (sub factors) include: 1) physical symptoms (tense/restless and somatic/autonomic); 2) social anxiety (humiliation/rejection and public performance fears); 3) harm avoidance (perfectionism and anxious coping); and 4) separation anxiety. Each item is scored on a 0-to-3-point scale (0–never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me).Total score range from 0 to 117. The higher the total score, the more severe the anxiety. Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value. Baseline for extension phase is defined as the last non-missing value in acute phase.
    End point type
    Secondary
    End point timeframe
    Baseline (extension phase), 39 weeks Analysis population description: All randomized participants who received at least one dose of study drug & had baseline & at least one post baseline MASC measurement.
    End point values
    		 Duloxetine/Duloxetine - Extension Phase Placebo/Duloxetine - Extension Phase
    Number of subjects analysed
    74
    74
    Units: units on a scale
    least squares mean (standard error)
        Physical Symptoms
    -0.63 ± 0.715
    -0.92 ± 0.692
        Harm Avoidance
    0.23 ± 0.485
    0.10 ± 0.471
        Social Anxiety
    -0.11 ± 0.487
    -0.02 ± 0.472
        Separation/Panic
    -0.06 ± 0.371
    0.01 ± 0.361
        Total Score
    -0.55 ± 1.478
    -0.78 ± 1.432
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 39 Weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Duloxetine - Acute
    Reporting group description
    		 -

    Reporting group title
    Placebo - Acute
    Reporting group description
    		 -

    Reporting group title
    Duloxetine/Duloxetine - Extension
    Reporting group description
    		 -

    Reporting group title
    Placebo/Duloxetine - Extension
    Reporting group description
    		 -

    Reporting group title
    Duloxetine/Duloxetine - Taper
    Reporting group description
    		 -

    Reporting group title
    Placebo/Placebo - Taper
    Reporting group description
    		 -

    Serious adverse events
    		 Duloxetine - Acute Placebo - Acute Duloxetine/Duloxetine - Extension Placebo/Duloxetine - Extension Duloxetine/Duloxetine - Taper Placebo/Placebo - Taper
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 93 (0.00%)
    3 / 74 (4.05%)
    3 / 75 (4.00%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    intentional overdose
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 74 (0.00%)
    1 / 75 (1.33%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    generalised tonic-clonic seizure
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 74 (0.00%)
    1 / 75 (1.33%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    affective disorder
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 74 (0.00%)
    1 / 75 (1.33%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hallucination, auditory
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 74 (0.00%)
    1 / 75 (1.33%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intentional self-injury
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    0 / 74 (0.00%)
    1 / 75 (1.33%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    suicidal ideation
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    0 / 74 (0.00%)
    1 / 75 (1.33%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    suicide attempt
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 93 (0.00%)
    2 / 74 (2.70%)
    0 / 75 (0.00%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    appendicitis
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 93 (0.00%)
    1 / 74 (1.35%)
    0 / 75 (0.00%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Duloxetine - Acute Placebo - Acute Duloxetine/Duloxetine - Extension Placebo/Duloxetine - Extension Duloxetine/Duloxetine - Taper Placebo/Placebo - Taper
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    74 / 91 (81.32%)
    58 / 93 (62.37%)
    52 / 74 (70.27%)
    54 / 75 (72.00%)
    8 / 77 (10.39%)
    0 / 3 (0.00%)
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    8 / 91 (8.79%)
    9 / 93 (9.68%)
    4 / 74 (5.41%)
    3 / 75 (4.00%)
    3 / 77 (3.90%)
    0 / 3 (0.00%)
         occurrences all number
    10
    13
    4
    4
    3
    0
    headache
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    13 / 91 (14.29%)
    10 / 93 (10.75%)
    6 / 74 (8.11%)
    5 / 75 (6.67%)
    1 / 77 (1.30%)
    0 / 3 (0.00%)
         occurrences all number
    15
    14
    8
    9
    1
    0
    somnolence
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    8 / 91 (8.79%)
    3 / 93 (3.23%)
    3 / 74 (4.05%)
    2 / 75 (2.67%)
    1 / 77 (1.30%)
    0 / 3 (0.00%)
         occurrences all number
    8
    3
    3
    2
    1
    0
    General disorders and administration site conditions
    fatigue
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    5 / 91 (5.49%)
    2 / 93 (2.15%)
    4 / 74 (5.41%)
    2 / 75 (2.67%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    5
    2
    4
    2
    0
    0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 91 (0.00%)
    2 / 93 (2.15%)
    0 / 74 (0.00%)
    4 / 75 (5.33%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    2
    0
    6
    0
    0
    abdominal pain upper
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    2 / 91 (2.20%)
    6 / 93 (6.45%)
    2 / 74 (2.70%)
    6 / 75 (8.00%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    2
    6
    2
    8
    0
    0
    constipation
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    2 / 91 (2.20%)
    2 / 93 (2.15%)
    2 / 74 (2.70%)
    4 / 75 (5.33%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    3
    2
    2
    4
    0
    0
    nausea
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    23 / 91 (25.27%)
    14 / 93 (15.05%)
    10 / 74 (13.51%)
    22 / 75 (29.33%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    30
    16
    14
    26
    0
    0
    vomiting
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    14 / 91 (15.38%)
    5 / 93 (5.38%)
    4 / 74 (5.41%)
    8 / 75 (10.67%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    19
    5
    4
    9
    0
    0
    Respiratory, thoracic and mediastinal disorders
    dysmenorrhoea
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed [1]
    2 / 73 (2.74%)
    4 / 65 (6.15%)
    2 / 61 (3.28%)
    2 / 53 (3.77%)
    0 / 60 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    6
    2
    5
    0
    0
    erectile dysfunction
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed [2]
    0 / 18 (0.00%)
    0 / 28 (0.00%)
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    0 / 17 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Psychiatric disorders
    insomnia
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    0 / 91 (0.00%)
    3 / 93 (3.23%)
    2 / 74 (2.70%)
    4 / 75 (5.33%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    0
    3
    2
    5
    0
    0
    Infections and infestations
    gastroenteritis viral
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    5 / 91 (5.49%)
    0 / 93 (0.00%)
    1 / 74 (1.35%)
    4 / 75 (5.33%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    6
    0
    1
    5
    0
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    8 / 91 (8.79%)
    2 / 93 (2.15%)
    3 / 74 (4.05%)
    4 / 75 (5.33%)
    1 / 77 (1.30%)
    0 / 3 (0.00%)
         occurrences all number
    11
    2
    3
    4
    1
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    6 / 91 (6.59%)
    2 / 93 (2.15%)
    6 / 74 (8.11%)
    4 / 75 (5.33%)
    1 / 77 (1.30%)
    0 / 3 (0.00%)
         occurrences all number
    6
    2
    6
    4
    1
    0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 20.1
         subjects affected / exposed
    14 / 91 (15.38%)
    3 / 93 (3.23%)
    6 / 74 (8.11%)
    8 / 75 (10.67%)
    0 / 77 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    14
    5
    6
    9
    0
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific adverse event, data posted is only for female subjects.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific adverse event, data posted is only for male subjects.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jul 2011
    Blood sample draw for pharmacogenomic assessment was moved from visit 8 to visit 1, if not withdrawn at visit 1 then it should be collected at visit 2 or at the earliest possible opportunity.
    24 Apr 2013
    Changes to inclusion & exclusion criteria. Discontinuation of patients was modified to include a stipulation that Lilly or its designee must be contacted if patients who do not meet enrollment criteria were inadvertently enrolled.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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