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    Clinical Trial Results:
    An Observational Study Providing 12 Months of Safety Follow-Up from First Exposure to HP802-247 in Subjects Who Participated in Study 802-247-09-032 (EU)

    Summary
    EudraCT number
    		 2013-000949-39
    Trial protocol
    		 HU   PL   DE   BE   CZ  
    Global end of trial date
    20 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Oct 2016
    First version publication date
    27 Oct 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    802-247-09-033
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01970657
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Smith & Nephew, Inc.
    Sponsor organisation address
    3909 Hulen street, Fort Worth, Texas, United States, 76107
    Public contact
    Jaime Dickerson, PhD VP Global Medical and Clinical Affairs, Smith & Nephew, Inc 3909 Hulen Street Fort Worth, TX 76107 United States, +1 8173023914,
    Scientific contact
    Jaime Dickerson, PhD VP Global Medical and Clinical Affairs, Smith & Nephew, Inc 3909 Hulen Street Fort Worth, TX 76107 United States, +1 8173023914,
    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 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Nov 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Nov 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess new adverse events and ongoing adverse events not resolved in subjects who were exposed to an Investigational Medicinal Product in the 802-247-09-032 trial (EudraCT number 2012-003286-18)
    Protection of trial subjects
    Only subjects that met all the study inclusion criteria and none of the exclusion criteria were to be entered in the study. All subjects were informed about the study and provided the opportunity to ask questions. Subjects, or their legal representatives, read, signed, and dated the IEC-approved consent form before taking part in any study activity.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Apr 2014
    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
    Poland: 101
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Czech Republic: 38
    Country: Number of subjects enrolled
    Germany: 37
    Country: Number of subjects enrolled
    Hungary: 41
    Worldwide total number of subjects
    221
    EEA total number of subjects
    221
    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)
    97
    From 65 to 84 years
    108
    85 years and over
    16

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled based on participation in the 802-247-09-032 trial (EudraCT number 2012-003286-18), evidenced by randomization in and completion (or discontinuation) of that trial and having received at least one application of test article.

    Pre-assignment
    Screening details
    		 The present study allowed subjects to transition immediately upon exit from the 802-247-09-032 trial (EudraCT number 2012-003286-18).

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer
    Blinding implementation details
    The group assignment was retained from the 802-247-09-032 trial (EudraCT number 2012-003286-18) and remained blinded to everyone, with the exception of the Sponsor, until the completion of this trial to prevent any bias being introduced into the assessments.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 HP802-247 (in 802-247-09-032 trial)
    Arm description
    		 Patients who received HP802-247 as treatment in the 802-247-09-032 trial (EudraCT number 2012-003286-18)
    Arm type
    		 Experimental

    Investigational medicinal product name
    HP802-247
    Investigational medicinal product code
    HP802-247
    Other name
    Pharmaceutical forms
    Cutaneous spray
    Routes of administration
    Topical use
    Dosage and administration details
    The product was administered in the 802-247-09-032 trial (EudraCT number 2012-003286-18). 260 µL of HP802-247 containing 0.5x106 cells/mL was administered every 14 days and Vehicle on the alternate weeks.

    Arm title
    		 Vehicle (in 802-247-09-032 trial)
    Arm description
    		 Patients who received the Vehicle as treatment in the 802-247-09-032 trial (EudraCT number 2012-003286-18)
    Arm type
    		 Control

    Investigational medicinal product name
    Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous spray
    Routes of administration
    Topical use
    Dosage and administration details
    The product was administered in the 802-247-09-032 trial (EudraCT number 2012-003286-18). 260µL of the vehicle formulation (fibrinogen solution and thrombin solution without cells) was administered every 7 days.

    Number of subjects in period 1
    		HP802-247 (in 802-247-09-032 trial) Vehicle (in 802-247-09-032 trial)
    Started
    115
    106
    Completed
    98
    95
    Not completed
    17
    11
         Consent withdrawn by subject
    2
    3
         Adverse events
    2
    3
         Lost to follow-up
    7
    2
         Scheduling error
    5
    3
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HP802-247 (in 802-247-09-032 trial)
    Reporting group description
    		 Patients who received HP802-247 as treatment in the 802-247-09-032 trial (EudraCT number 2012-003286-18)

    Reporting group title
    Vehicle (in 802-247-09-032 trial)
    Reporting group description
    		 Patients who received the Vehicle as treatment in the 802-247-09-032 trial (EudraCT number 2012-003286-18)

    Reporting group values
    		 HP802-247 (in 802-247-09-032 trial) Vehicle (in 802-247-09-032 trial) Total
    Number of subjects
    		 115 106 221
    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)
    		 0 0 0
        Adults (18-64 years)
    		 55 42 97
        From 65-84 years
    		 53 55 108
        85 years and over
    		 7 9 16
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.8 ( 13 ) 67.7 ( 12.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 68 56 124
        Male
    		 47 50 97
    Subject analysis sets

    Subject analysis set title
    HP802-247 (in 802-247-09-032 trial) - ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All enrolled subjects in the HP802-247 arm who had at least one assessment of ulcer status post-enrollment. The ITT population was the primary dataset for the evaluation of efficacy persistence.

    Subject analysis set title
    Vehicle (in 802-247-09-032 trial) - ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All enrolled subjects in the Vehicle arm who had at least one assessment of ulcer status post-enrollment. The ITT population was the primary dataset for the evaluation of efficacy persistence.

    Subject analysis sets values
    		 HP802-247 (in 802-247-09-032 trial) - ITT Vehicle (in 802-247-09-032 trial) - ITT
    Number of subjects
    112
    105
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    52
    42
        From 65-84 years
    53
    55
        85 years and over
    7
    8
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    65 ( 13.1 )
    67.5 ( 12.8 )
    Gender categorical
    Units: Subjects
        Female
    66
    56
        Male
    46
    49

    End points

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    End points reporting groups
    Reporting group title
    HP802-247 (in 802-247-09-032 trial)
    Reporting group description
    		 Patients who received HP802-247 as treatment in the 802-247-09-032 trial (EudraCT number 2012-003286-18)

    Reporting group title
    Vehicle (in 802-247-09-032 trial)
    Reporting group description
    		 Patients who received the Vehicle as treatment in the 802-247-09-032 trial (EudraCT number 2012-003286-18)

    Subject analysis set title
    HP802-247 (in 802-247-09-032 trial) - ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All enrolled subjects in the HP802-247 arm who had at least one assessment of ulcer status post-enrollment. The ITT population was the primary dataset for the evaluation of efficacy persistence.

    Subject analysis set title
    Vehicle (in 802-247-09-032 trial) - ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All enrolled subjects in the Vehicle arm who had at least one assessment of ulcer status post-enrollment. The ITT population was the primary dataset for the evaluation of efficacy persistence.

    Primary: Proportion of subjects with persistent ulcer closure over the duration of the study for those subjects who had achieved confirmed ulcer closure in the 802-247-09-032 study.

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    End point title
    		 Proportion of subjects with persistent ulcer closure over the duration of the study for those subjects who had achieved confirmed ulcer closure in the 802-247-09-032 study.
    End point description
    End point type
    Primary
    End point timeframe
    From Week 08 to End of follow-up
    End point values
    		 HP802-247 (in 802-247-09-032 trial) - ITT Vehicle (in 802-247-09-032 trial) - ITT
    Number of subjects analysed
    57 [1]
    57 [2]
    Units: Percentage of Subjects
    number (not applicable)
        Ulcer not closed
    12.3
    10.5
        Ulcer closed
    87.7
    89.5
    Notes
    [1] - Only subjects with confirmed closure from the prior study were included in this end point
    [2] - Only subjects with confirmed closure from the prior study were included in this end point
    Statistical analysis title
    		 Durable Ulcer Closure at End of Follow-Up Visit
    Comparison groups
    Vehicle (in 802-247-09-032 trial) - ITT v HP802-247 (in 802-247-09-032 trial) - ITT
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1 [3]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [3] - p-value was based on the Fisher’s Exact Test

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The evaluation of safety was conducted from the Enrollment visit (Visit 0) until the End of follow-up visit.
    Adverse event reporting additional description
    The evaluation of safety included analysis of new test article-related events, as well as continued follow-up of those adverse events that originated in the 802-247-09-032 trial (EudraCT number 2012-003286-18)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    HP802-247 (in 802-247-09-032 trial)
    Reporting group description
    		 Subjects enrolled in the current study and who recieved HP802-247 as treatment in the 802-247-09-032 trial (EudraCT number 2012-003286-18)

    Reporting group title
    Vehicle (in 802-247-09-032 trial)
    Reporting group description
    		 Subjects enrolled in the current study and who recieved the Vehicle as treatment in the 802-247-09-032 trial (EudraCT number 2012-003286-18)

    Serious adverse events
    		 HP802-247 (in 802-247-09-032 trial) Vehicle (in 802-247-09-032 trial)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 115 (13.04%)
    15 / 106 (14.15%)
         number of deaths (all causes)
    3
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatic neoplasm
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penile cancer
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cardiac pacemaker replacement
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 115 (0.00%)
    2 / 106 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Impaired healing
         subjects affected / exposed
    2 / 115 (1.74%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column injury
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block left
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Keratitis
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Umbilical hernia, obstructive
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct obstruction
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Eczema nummular
         subjects affected / exposed
    1 / 115 (0.87%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    1 / 115 (0.87%)
    3 / 106 (2.83%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stasis dermatitis
         subjects affected / exposed
    0 / 115 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    2 / 115 (1.74%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    1 / 115 (0.87%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 HP802-247 (in 802-247-09-032 trial) Vehicle (in 802-247-09-032 trial)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 115 (46.09%)
    56 / 106 (52.83%)
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    4 / 115 (3.48%)
    1 / 106 (0.94%)
         occurrences all number
    4
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 115 (4.35%)
    3 / 106 (2.83%)
         occurrences all number
    6
    3
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    4 / 115 (3.48%)
    3 / 106 (2.83%)
         occurrences all number
    4
    4
    Eczema
         subjects affected / exposed
    4 / 115 (3.48%)
    5 / 106 (4.72%)
         occurrences all number
    4
    5
    Pruritus
         subjects affected / exposed
    4 / 115 (3.48%)
    2 / 106 (1.89%)
         occurrences all number
    4
    2
    Skin ulcer
         subjects affected / exposed
    25 / 115 (21.74%)
    22 / 106 (20.75%)
         occurrences all number
    40
    47
    Venous ulcer pain
         subjects affected / exposed
    1 / 115 (0.87%)
    4 / 106 (3.77%)
         occurrences all number
    1
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 115 (3.48%)
    1 / 106 (0.94%)
         occurrences all number
    4
    1
    Pain in extremity
         subjects affected / exposed
    0 / 115 (0.00%)
    4 / 106 (3.77%)
         occurrences all number
    0
    4
    Infections and infestations
    Infected skin ulcer
         subjects affected / exposed
    2 / 115 (1.74%)
    5 / 106 (4.72%)
         occurrences all number
    2
    6
    Urinary tract infection
         subjects affected / exposed
    1 / 115 (0.87%)
    5 / 106 (4.72%)
         occurrences all number
    1
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jul 2013
    The amendment prescribed procedures for the handling of missing and incomplete data.

    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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