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    Clinical Trial Results:
    Validation Study to Investigate the Effect of T4P1010 treatment in Patients with Osteoarthritic Pain of Knee or Hip.

    Summary
    EudraCT number
    		 2017-001028-23
    Trial protocol
    		 BE   FR  
    Global end of trial date
    24 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Sep 2019
    First version publication date
    08 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    T1010-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03174145
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Tools4Patient
    Sponsor organisation address
    Rue de Bordeaux, 50 - Boîte 17, Jumet, Belgium, 6040
    Public contact
    Clinical Trial Information, Tools4Patient SA, T1010-01@tools4patient.com
    Scientific contact
    Clinical Trial Information, Tools4Patient SA, T1010-01@tools4patient.com
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Jul 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the relationship between the patient’s profile (as defined by his/her disease history, personality characteristics, expectations, genetic profile and demographic characteristics) and his/her placebo response, as defined by the analgesic effect measured by Average Pain Score (APS) reduction after a placebo treatment on osteoarthritic (OA) pain of knee or hip.
    Protection of trial subjects
    No specific measures
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Sep 2017
    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
    Belgium: 7
    Country: Number of subjects enrolled
    France: 31
    Country: Number of subjects enrolled
    United Kingdom: 35
    Worldwide total number of subjects
    73
    EEA total number of subjects
    73
    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)
    0
    Adults (18-64 years)
    36
    From 65 to 84 years
    37
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients with osteoarthritis (OA) of knee or hip diagnosed since at least 6 months and pain scores reported during the baseline period with a mean APS between 3.6 and 8.4 inclusive

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active Group
    Arm description
    		 Patients received T4P1010 treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cornstarch
    Investigational medicinal product code
    T4P1010
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule twice a day, ideally in the morning between 7 and 10 a.m. and in the evening between 6 and 9 p.m

    Arm title
    		 Control Group
    Arm description
    		 Patients followed the control procedures, without T4P1010 treatment
    Arm type
    		 Control

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Active Group Control Group
    Started
    60
    13
    Completed
    60
    12
    Not completed
    0
    1
         Consent withdrawn by subject
    -
    1
    Period 2
    Period 2 title
    End of Treatment (Week 12)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active Group
    Arm description
    		 Patients received T4P1010 treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cornstarch
    Investigational medicinal product code
    T4P1010
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule twice a day, ideally in the morning between 7 and 10 a.m. and in the evening between 6 and 9 p.m

    Arm title
    		 Control Group
    Arm description
    		 Patients followed the control procedures, without T4P1010 treatment
    Arm type
    		 Control

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Active Group Control Group
    Started
    60
    12
    Completed
    56
    11
    Not completed
    4
    1
         Protocol deviation
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 73 73
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.0 ± 10.4 -
    Gender categorical
    Units: Subjects
        Female
    		 34 34
        Male
    		 39 39

    End points

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    End points reporting groups
    Reporting group title
    Active Group
    Reporting group description
    		 Patients received T4P1010 treatment

    Reporting group title
    Control Group
    Reporting group description
    		 Patients followed the control procedures, without T4P1010 treatment
    Reporting group title
    Active Group
    Reporting group description
    		 Patients received T4P1010 treatment

    Reporting group title
    Control Group
    Reporting group description
    		 Patients followed the control procedures, without T4P1010 treatment

    Primary: Analgesic efficacy (APS)

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    End point title
    		 Analgesic efficacy (APS)
    End point description
    The patient’s change from baseline of pain severity, as measured by the weekly means of the daily APS in the last 24 hours in patients with OA pain of knee or hip during a 12-week treatment therapy period
    End point type
    Primary
    End point timeframe
    Change from baseline during a 12-week treatment therapy period
    End point values
    		 Active Group Control Group Active Group Control Group
    Number of subjects analysed
    56 [1]
    11 [2]
    56 [3]
    11 [4]
    Units: 11-point NRS scale
        arithmetic mean (standard deviation)
    5.04 ± 1.09
    5.05 ± 0.98
    3.75 ± 1.72
    4.55 ± 1.5
    Notes
    [1] - Analysis on the patients completing the study per protocol
    [2] - Analysis on the patients completing the study per protocol
    [3] - Analysis on the patients completing the study per protocol
    [4] - Analysis on the patients completing the study per protocol
    Statistical analysis title
    		 t-test
    Comparison groups
    Active Group v Control Group v Active Group v Control Group
    Number of subjects included in analysis
    134
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8532
         upper limit
    		 0.2532
    Variability estimate
    Standard deviation

    Secondary: Analgesic outcome (WOMAC)

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    End point title
    		 Analgesic outcome (WOMAC)
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline of during a 12-week treatment therapy period
    End point values
    		 Active Group Control Group Active Group Control Group
    Number of subjects analysed
    56 [5]
    11 [6]
    56 [7]
    11 [8]
    Units: Scale
    arithmetic mean (standard deviation)
        Womac-Pain
    10.15 ± 2.79
    11.18 ± 1.83
    7.23 ± 3.41
    9.27 ± 3.64
        Womac-Stiff
    4.68 ± 1.41
    5.18 ± 1.17
    3.75 ± 1.64
    5.09 ± 1.51
        Womac-Phys
    35.72 ± 9.03
    39.36 ± 7.19
    25.06 ± 11.75
    35.29 ± 11.67
        Womac-Glob
    16.18 ± 3.79
    17.86 ± 2.42
    11.99 ± 4.99
    16.19 ± 4.73
    Notes
    [5] - Analysis on the patients completing the study per protocol
    [6] - Analysis on the patients completing the study per protocol
    [7] - Analysis on the patients completing the study per protocol
    [8] - Analysis on the patients completing the study per protocol
    No statistical analyses for this end point

    Secondary: Analgesic outcome (BPI)

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    End point title
    		 Analgesic outcome (BPI)
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline of during a 12-week treatment therapy period
    End point values
    		 Active Group Control Group Active Group Control Group
    Number of subjects analysed
    56 [9]
    11 [10]
    56 [11]
    11 [12]
    Units: Scale
    arithmetic mean (standard deviation)
        BPI-Severity subscale
    4.97 ± 1.37
    4.86 ± 1.17
    3.63 ± 1.81
    5.09 ± 1.63
        BPI-Interference
    4.55 ± 1.82
    4.81 ± 1.19
    2.87 ± 2.02
    3.64 ± 1.69
        BPI-Effect
    35.83 ± 21.25
    51.67 ± 20.41
    45.00 ± 24.49
    42.00 ± 19.24
    Notes
    [9] - Analysis on the patients completing the study per protocol
    [10] - Analysis on the patients completing the study per protocol
    [11] - Analysis on the patients completing the study per protocol
    [12] - Analysis on the patients completing the study per protocol
    No statistical analyses for this end point

    Secondary: Analgesic outcome (WPS)

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    End point title
    		 Analgesic outcome (WPS)
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline of during a 12-week treatment therapy period
    End point values
    		 Active Group Control Group Active Group Control Group
    Number of subjects analysed
    56 [13]
    11 [14]
    56 [15]
    11 [16]
    Units: Scale
        arithmetic mean (standard deviation)
    6.73 ± 1.16
    7.03 ± 1.31
    5.39 ± 2.03
    6.77 ± 1.59
    Notes
    [13] - Analysis on the patients completing the study per protocol
    [14] - Analysis on the patients completing the study per protocol
    [15] - Analysis on the patients completing the study per protocol
    [16] - Analysis on the patients completing the study per protocol
    No statistical analyses for this end point

    Secondary: Analgesic outcome (LPS)

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    End point title
    		 Analgesic outcome (LPS)
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline of during a 12-week treatment therapy period
    End point values
    		 Active Group Control Group Active Group Control Group
    Number of subjects analysed
    56 [17]
    11 [18]
    56 [19]
    11 [20]
    Units: Scale
        arithmetic mean (standard deviation)
    3.48 ± 1.75
    3.55 ± 1.41
    2.39 ± 1.80
    3.06 ± 1.55
    Notes
    [17] - Analysis on the patients completing the study per protocol
    [18] - Analysis on the patients completing the study per protocol
    [19] - Analysis on the patients completing the study per protocol
    [20] - Analysis on the patients completing the study per protocol
    No statistical analyses for this end point

    Secondary: Analgesic outcome (IGAC and PGAC)

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    End point title
    		 Analgesic outcome (IGAC and PGAC)
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline of during a 12-week treatment therapy period
    End point values
    		 Active Group Control Group Active Group Control Group
    Number of subjects analysed
    56
    11
    56
    11
    Units: Scale
    arithmetic mean (standard deviation)
        PGAC
    5.17 ± 1.60
    4.36 ± 1.80
    5.55 ± 2.32
    4.73 ± 1.90
        IGAC
    5.23 ± 1.50
    5.09 ± 1.30
    5.28 ± 2.16
    4.82 ± 1.89
    No statistical analyses for this end point

    Secondary: Personality characteristics outcomes

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    End point title
    		 Personality characteristics outcomes
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline of during a 12-week treatment therapy period
    End point values
    		 Active Group Control Group Active Group Control Group
    Number of subjects analysed
    56
    11
    56
    11
    Units: Cronbach's alpha
        number (not applicable)
    80.6
    80.6
    80.6
    80.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    At each visit during treatment period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Active Group
    Reporting group description
    		 Patients received T4P1010 treatment

    Reporting group title
    Control Group
    Reporting group description
    		 Patients followed the control procedures, without T4P1010 treatment

    Serious adverse events
    		 Active Group Control Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 12 (8.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Skin and subcutaneous tissue disorders
    Erythema
    Additional description: Patient reported a 5-days hospitalization due to pain in extremity and erythema, resolving 6 days later. The Investigator concluded that the 2 reported SAEs were not related to Study drug or to Protocol procedures and possibly due to previous gout
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
    Additional description: Patient reported a 5-days hospitalization due to pain in extremity and erythema, resolving 6 days later. The Investigator concluded that the 2 reported SAEs were not related to Study drug or to Protocol procedures and possibly due to previous gout
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Erysipelas
    Additional description: Patient was hospitalized for 1 day following a cat bite on the left calf and diagnosed erysipelas. The SAE was therefore not related to Study Drug or to Study procedures, as supported by the Investigator conclusion.
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Active Group Control Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 60 (16.67%)
    3 / 12 (25.00%)
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    3 / 60 (5.00%)
    0 / 12 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 60 (3.33%)
    1 / 12 (8.33%)
         occurrences all number
    2
    1
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    5 / 60 (8.33%)
    2 / 12 (16.67%)
         occurrences all number
    6
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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