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    Clinical Trial Results:
    Treatment of rotator cuff syndrome and bursitis: A double blind, controlled trial to assess the efficacy and safety of Traumeel® S injection versus corticosteroid injections and versus placebo TRARO (Traumeel® S in Rotator Cuff Syndrome)-Study

    Summary
    EudraCT number
    		 2012-003393-12
    Trial protocol
    		 DE   BE   ES  
    Global end of trial date
    24 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jun 2016
    First version publication date
    15 Jun 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TRARO
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01702233
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Biologische Heilmittel Heel GmbH
    Sponsor organisation address
    Dr. Reckeweg-Str. 2-4, Baden-Baden, Germany, 76532
    Public contact
    Dr. Istvan Zatik, Biologische Heilmittel Heel GmbH, +49 7221-5010, info@heel.com
    Scientific contact
    Dr. Myron Schultz, Biologische Heilmittel Heel GmbH, +49 7221-5010, info@heel.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
    24 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jun 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of subjective parameters in patients with rotator cuff syndrome and bursitis by visual analogue scale (VAS).
    Protection of trial subjects
    Standard protection of trial subjects according to ICH GCP requirements was applied.
    Background therapy
    		 Paracetamol (500 mg PRN) was permitted during the study as rescue medication for pain relief with a maximal daily dose of 2000 mg. No Paracetamol intake was allowed within 24 hours before any efficacy measures.
    Evidence for comparator
    		 Periarticular injection of dexamethasone is the established medication for treatment of shoulder conditions such as rotator cuff syndrome and Bursitis.
    Actual start date of recruitment
    16 Apr 2013
    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
    Spain: 38
    Country: Number of subjects enrolled
    Germany: 129
    Country: Number of subjects enrolled
    Belgium: 9
    Worldwide total number of subjects
    176
    EEA total number of subjects
    176
    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)
    172
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was carried out in 10 sites in Europe: 2 sites in Belgium, 4 in Germany and 4 in Spain. The recruitment phase was completed when patients were enrolled, and the planned duration of recruitment period was about 12 months. Enrolment started in April 2013; the last Patient was enroled in February 2014 to the study. LPLV was on 24 June 2014

    Pre-assignment
    Screening details
    		 Observations/procedures performed and checked included check of inclusion/exclusion criteria, completion of physical examination and medical history, bilateral shoulder examination, VAS measurement, bilateral examination of ROM, Jobe/Painful Arc tests and DASH score, dispensation of 500 mg paracetamol as rescue medication for pain relief etc.

    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
    Patients were randomly allocated to Traumeel® S, dexamethasone, or placebo in a 2:2:1 randomization. The randomization was stratified by site. The patients were randomized in ascending order of the site-specific randomization list.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Traumeel Safety Group
    Arm description
    		 72 subjects received 2ml Traumeel once a week for 3 continuous weeks, using ultrasound-guided subacromial periarticular injection. Randomized patients who received at least one injection of study medication form the Safety Analysis Set. The Safety Analysis Set was used for all analyses of safety, tolerability, and Background characteristics.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Traumeel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Periarticular use
    Dosage and administration details
    One ampoule of 2 ml Traumeel contains: Calendula officinalis, 2 mg, (Dil. D2) Atropa Belladonna, 2 mg, (Dil. D2) Aconitum napellus, 1.2 mg, (Dil. D2) Bellis perennis, 1mg, (Dil. D2) Hypericum perforatum, 0.6 mg, (Dil. D2) Echinacea, 0.5 mg, (Dil. D2) Echinacea purpurea, 0.5 mg, (Dil. D2) Symphytum officinale 2 mg (Dil. D6) Matricaria recutita, 2 mg, (Dil. D3) Achillea millefolium, 2 mg, (Dil. D3) Mercurius solubilis Hahnemanni, 1 mg, (Dil. D6) Hepar sulfuris, 2 mg, (Dil. D6) Hamamelis virginiana 0.2 mg, (Dil. D1) Arnica montana, 2 mg, (Dil. D2) Route of administration: periarticular use Total administered: 6 ml (2 ml/week for 3 weeks)

    Arm title
    		 Fortecortin Safety Group
    Arm description
    		 67 participants were randomized to Fortecortin. The subjects received 2ml Fortecortin once a week for 3 continuous weeks, using ultrasound-guided subacromial periarticular injection. Randomized patients who received at least one injection of study medication form the Safety Analysis Set. The Safety Analysis Set was used for all analyses of safety, tolerability, and Background characteristics.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fortecortin (dexamethasone)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Periarticular use
    Dosage and administration details
    One vial of 2 ml Fortecortin contains 8 mg dexamethasone. Route of administration: periarticular use Total administered: 6 ml (2 ml/week for 3 weeks), i.e. 48 mg dexamethasone

    Arm title
    		 Placebo Safety Group
    Arm description
    		 36 participants were randomized to placebo. The subjects received 2ml placebo once a week for 3 continuous weeks, using ultrasound-guided subacromial periarticular injection. Randomized patients who received at least one injection of study medication form the Safety Analysis Set. The Safety Analysis Set was used for all analyses of safety, tolerability, and Background characteristics.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Periarticular use
    Dosage and administration details
    One ampoule of 2 ml placebo containing sodium chloride and water for injections, was administered once per week for 3 weeks.

    Number of subjects in period 1 [1]
    		Traumeel Safety Group Fortecortin Safety Group Placebo Safety Group
    Started
    72
    67
    36
    Completed
    67
    64
    31
    Not completed
    5
    3
    5
         Consent withdrawn by subject
    1
    -
    -
         Physician decision
    2
    -
    -
         Adverse event, non-fatal
    -
    2
    2
         private problems, broken ampoules
    -
    -
    2
         Lack of efficacy
    2
    1
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 176 subjects were randomized, 1 subject (Traumeel S group) was not treated. Thus, 175 of the randomized patients were included in the Safety Set, 72 patients in the Traumeel S group, 67 patients in the Fortecortin group and 36 patients in the Placebo group. The Safety Analysis Set was used for all analyses of safety, tolerability, and background characteristics.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Traumeel Safety Group
    Reporting group description
    		 72 subjects received 2ml Traumeel once a week for 3 continuous weeks, using ultrasound-guided subacromial periarticular injection. Randomized patients who received at least one injection of study medication form the Safety Analysis Set. The Safety Analysis Set was used for all analyses of safety, tolerability, and Background characteristics.

    Reporting group title
    Fortecortin Safety Group
    Reporting group description
    		 67 participants were randomized to Fortecortin. The subjects received 2ml Fortecortin once a week for 3 continuous weeks, using ultrasound-guided subacromial periarticular injection. Randomized patients who received at least one injection of study medication form the Safety Analysis Set. The Safety Analysis Set was used for all analyses of safety, tolerability, and Background characteristics.

    Reporting group title
    Placebo Safety Group
    Reporting group description
    		 36 participants were randomized to placebo. The subjects received 2ml placebo once a week for 3 continuous weeks, using ultrasound-guided subacromial periarticular injection. Randomized patients who received at least one injection of study medication form the Safety Analysis Set. The Safety Analysis Set was used for all analyses of safety, tolerability, and Background characteristics.

    Reporting group values
    		 Traumeel Safety Group Fortecortin Safety Group Placebo Safety Group Total
    Number of subjects
    		 72 67 36 175
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 69 66 36 171
        From 65-84 years
    		 3 1 0 4
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51 ( 6.9 ) 51.9 ( 7.02 ) 51.8 ( 6.74 ) -
    Gender categorical
    Units: Subjects
        Female
    		 41 37 20 98
        Male
    		 31 30 16 77
    Ethnic group
    Units: Subjects
        White
    		 71 66 35 172
        Black
    		 1 0 0 1
        Asian
    		 0 0 0 0
        Other
    		 0 1 1 2
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 171.3 ( 10.24 ) 170.6 ( 8.01 ) 169.9 ( 11.32 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 76.4 ( 16.57 ) 79.2 ( 14.9 ) 78.8 ( 16.9 ) -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 25.92 ( 4.455 ) 27.29 ( 5.455 ) 27.14 ( 4.382 ) -

    End points

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    End points reporting groups
    Reporting group title
    Traumeel Safety Group
    Reporting group description
    		 72 subjects received 2ml Traumeel once a week for 3 continuous weeks, using ultrasound-guided subacromial periarticular injection. Randomized patients who received at least one injection of study medication form the Safety Analysis Set. The Safety Analysis Set was used for all analyses of safety, tolerability, and Background characteristics.

    Reporting group title
    Fortecortin Safety Group
    Reporting group description
    		 67 participants were randomized to Fortecortin. The subjects received 2ml Fortecortin once a week for 3 continuous weeks, using ultrasound-guided subacromial periarticular injection. Randomized patients who received at least one injection of study medication form the Safety Analysis Set. The Safety Analysis Set was used for all analyses of safety, tolerability, and Background characteristics.

    Reporting group title
    Placebo Safety Group
    Reporting group description
    		 36 participants were randomized to placebo. The subjects received 2ml placebo once a week for 3 continuous weeks, using ultrasound-guided subacromial periarticular injection. Randomized patients who received at least one injection of study medication form the Safety Analysis Set. The Safety Analysis Set was used for all analyses of safety, tolerability, and Background characteristics.

    Subject analysis set title
    Traumeel S Per-Protocol Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in the Full Analysis Set (subset of the Safety Analysis Set) without major protocol deviations formed the Per-Protocol Set. The PP Set was used as the primary population for the analysis of efficacy.

    Subject analysis set title
    Fortecortin Per-Protocol Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in the Full Analysis Set (subset of the Safety Analysis Set) without major protocol deviations formed the Per-Protocol Set. The PP Set was used as the primary population for the analysis of efficacy.

    Subject analysis set title
    Placebo Per-Protocol Set
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in the Full Analysis Set (subset of the Safety Analysis Set) without major protocol deviations formed the Per-Protocol Set. The PP Set was used as the primary population for the analysis of efficacy.

    Primary: Abduction rotation pain VAS for active external rotation at day 22 (Traumeel vs Fortecortin)

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    End point title
    		 Abduction rotation pain VAS for active external rotation at day 22 (Traumeel vs Fortecortin)
    End point description
    Primary Efficacy Variable was the change from baseline in VAS for abduction rotation pain at Visit 5 (Day 22) (Traumeel S injections versus corticoid injections) for active external rotation.
    End point type
    Primary
    End point timeframe
    Screening (max. -7 days, visit 1), Day 1 Baseline (visit 2) Day 22 ± 1 day (visit 5)
    End point values
    		 Traumeel S Per-Protocol Set Fortecortin Per-Protocol Set Placebo Per-Protocol Set
    Number of subjects analysed
    58
    58
    27
    Units: mm
    arithmetic mean (standard deviation)
        Baseline
    58.2 ( 19.76 )
    61 ( 17.87 )
    55.6 ( 18.43 )
        Visit 5
    39.5 ( 25.2 )
    33.8 ( 26.17 )
    38.5 ( 24.49 )
        Change from baseline
    -18.7 ( 21.49 )
    -27.2 ( 23.44 )
    -17.1 ( 23.94 )
    Statistical analysis title
    		 Analysis of primary endpoint
    Statistical analysis description
    A one-sided test of non-inferiority of Traumeel® S with respect to dexamethasone at Level 0.025 was computed using an analysis of covariance (ANCOVA) model with treatment group and centre as qualitative factors and the baseline value of the abduction rotation pain VAS for active external rotation as a covariate.
    Comparison groups
    Fortecortin Per-Protocol Set v Traumeel S Per-Protocol Set
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    		 ANCOVA
    Parameter type
    		 least squares mean difference
    Point estimate
    7.62
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 15.74
    Variability estimate
    Standard deviation
    Dispersion value
    4.11
    Notes
    [1] - The test decision was based on a one-sided 97.5% confidence interval for the corresponding Treatment difference. The non-inferiority margin was set to 13 mm on a 0 - 100 mm VAS scale.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening (max. -7 days), Baseline, Day 1, Day 8 ± 1 day, Day 15 ± 1 day, Day 22 ± 1 day, Week 9 ± 3 days, Week 15 ± 3 days
    Adverse event reporting additional description
    All AEs, occurred after the patient signed the IC were collected and reported on eCRF, regardless of whether they were reported by the patient, elicited by investigator questioning, detected through physical examination, or by other means. 86/175 treated patients (49%) reported 197 (s)AEs. 78 patients reported 171 TEAEs after 1st IMP Administration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Traumeel Safety Group
    Reporting group description
    		 Randomized patients who received at least one injection of study medication form the Safety Analysis Set. The Safety Analysis Set was used for all analyses of safety, tolerability, and background characteristics.

    Reporting group title
    Fortecortin Safety Group
    Reporting group description
    		 Randomized patients who received at least one injection of study medication form the Safety Analysis Set. The Safety Analysis Set was used for all analyses of safety, tolerability, and background characteristics.

    Reporting group title
    Placebo Safety Group
    Reporting group description
    		 Randomized patients who received at least one injection of study medication form the Safety Analysis Set. The Safety Analysis Set was used for all analyses of safety, tolerability, and background characteristics.

    Serious adverse events
    		 Traumeel Safety Group Fortecortin Safety Group Placebo Safety Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    auricular (atrial) fibrillation
    Additional description: The SAE was severe and led to discontinuation of study drug after the first injection, the patient recovered. SAE was considered as „unrelated“ due to delayed occurrence following 1st injection and due to pre-existing disease.
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Traumeel Safety Group Fortecortin Safety Group Placebo Safety Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 72 (45.83%)
    29 / 67 (43.28%)
    16 / 36 (44.44%)
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    Flushing
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    Hypertension
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    1 / 36 (2.78%)
         occurrences all number
    0
    1
    1
    Surgical and medical procedures
    Dental implantation
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    injection site haematoma
         subjects affected / exposed
    2 / 72 (2.78%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences all number
    2
    1
    0
    Injection site joint effusion
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    1
    Injection site pain
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 72 (1.39%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    Immune system disorders
    hypersensitivity
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    seasonal allergy
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 67 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 72 (1.39%)
    3 / 67 (4.48%)
    2 / 36 (5.56%)
         occurrences all number
    1
    3
    2
    Pleurisy
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 67 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    Loss of libido
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    1
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    Blood uric acid increased
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 67 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 72 (1.39%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences all number
    1
    1
    0
    Fall
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 67 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    0
    Ligament sprain
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 67 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    Tendon rupture
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 67 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Cervicobrachial syndrome
         subjects affected / exposed
    3 / 72 (4.17%)
    0 / 67 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    3
    0
    1
    Formication
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    1
    Headache
         subjects affected / exposed
    12 / 72 (16.67%)
    11 / 67 (16.42%)
    3 / 36 (8.33%)
         occurrences all number
    12
    11
    3
    Hypertonia
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    Intercostal neuralgia
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    1
    Paraesthesia
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 67 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 67 (2.99%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    1
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 67 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    Toothache
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 67 (2.99%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 67 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    Rash erythematous
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 72 (1.39%)
    1 / 67 (1.49%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    1
    Back pain
         subjects affected / exposed
    3 / 72 (4.17%)
    1 / 67 (1.49%)
    3 / 36 (8.33%)
         occurrences all number
    3
    1
    3
    Foot deformity
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    1
    Gouty arthritis
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 67 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 67 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    Myalgia
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 67 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    0
    Neck pain
         subjects affected / exposed
    4 / 72 (5.56%)
    2 / 67 (2.99%)
    2 / 36 (5.56%)
         occurrences all number
    4
    2
    2
    Pain in extremity
         subjects affected / exposed
    1 / 72 (1.39%)
    2 / 67 (2.99%)
    1 / 36 (2.78%)
         occurrences all number
    1
    2
    1
    Periarthritis
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 67 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 67 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    bronchitis
         subjects affected / exposed
    1 / 72 (1.39%)
    1 / 67 (1.49%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    1
    Influenza
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    Lice infestation
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 72 (2.78%)
    2 / 67 (2.99%)
    0 / 36 (0.00%)
         occurrences all number
    2
    2
    0
    Oral herpes
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 67 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    0
    1
    Periodontitis
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 67 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 67 (1.49%)
    0 / 36 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 67 (0.00%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Feb 2014
    1. The number of patients to be enrolled was to be increased to 175 (instead of 160) patients to achieve a sufficient number of evaluable patients: Patients were not eligible for the per protocol analysis for the following reasons: a. methodology issues with performing the VAS as per protocol. A total of 11 patients was inadvertently instructed to perfom the VAS scoring differently from protocol, one patient performed the VAS scoring on one form for all visits and the visit could not be referenced thereafter and in one patient the VAS was not performed adequately at baseline. b. There were some drop-outs for the following reasons: Patients do not meet inclusion criteria (calcifications), in one case the patient was employed at site and in one case the random code was found open.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/15593187
    http://www.ncbi.nlm.nih.gov/pubmed/8326275
    http://www.ncbi.nlm.nih.gov/pubmed/10839557
    http://www.ncbi.nlm.nih.gov/pubmed/17720798
    For support, Contact us.
    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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