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    Clinical Trial Results:
    Intra-articular treatment with MEN16132 in patients with symptomatic primary osteoarthritis of the knee: A randomised, multicentre, double blind, placebo controlled, five parallel group, dose finding study

    Summary
    EudraCT number
    		 2009-014918-99
    Trial protocol
    		 DE   IT   ES  
    Global end of trial date
    31 May 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Nov 2018
    First version publication date
    09 Nov 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BKOS-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01091116
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Menarini Ricerche S.p.A.
    Sponsor organisation address
    Via Sette Santi 1, Florence, Italy, 50131
    Public contact
    Corporate Clinical Sciences, Menarini Ricerche S.p.A., 0039 05556809990, acapriati@menarini-ricerche.it
    Scientific contact
    Corporate Clinical Sciences, Menarini Ricerche S.p.A., 0039 05556809990, acapriati@menarini-ricerche.it
    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
    31 May 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of MEN16132 given by intra-articular injections as four different doses/regimens versus placebo
    Protection of trial subjects
    If any event(s) related to the conduct of the study or the development of the IMP affects the safety of the study participants, the Sponsor and the Investigator will take appropriate urgent safety measures to protect the patients against any immediate hazard. The CAs and IRB/ECs will be informed forthwith about these new events and the measures taken. For patients participating in the study, Menarini Ricerche S.p.A. has stipulated an insurance policy in accordance with local regulatory requirements. Details on the insurance company, the insurance number and conditions were made available to patients in the ICF and/or provided in a separate document in accordance with national requirements
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Feb 2010
    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: 52
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 353
    Country: Number of subjects enrolled
    Italy: 10
    Worldwide total number of subjects
    423
    EEA total number of subjects
    423
    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)
    174
    From 65 to 84 years
    247
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted in 23 sites in France (2 sites), Germany (12 sites), Italy (4 sites) and Spain (4 sites). The first patient was enroled on 24 February 2010 and the last patient completed the study on 31 May 2011.

    Pre-assignment
    Screening details
    		 504 patients were screened during the up to 3 weeks screening period of which 423 patients with mild to moderate idiopathic osteoarthritis were randomised. The resulting screening failure rate was 16%.

    Period 1
    Period 1 title
    Interventional Phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Assessor
    Blinding implementation details
    Eligible patients were randomised to one out of five treatment arms, with a 1:1:1:1 randomisation ratio and site balance delivered through IxRS.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Low dose
    Arm description
    		 Fasitibant 2x0.125 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fasitibant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Dose: 0.125 mg fasitibant in 1 mL solution for IA injection single treatment course, consisting of 2 injections at 2-weeks intervall: 0.125 mg followed by 0.125 mg

    Arm title
    		 Mid dose
    Arm description
    		 Fasitibant 2x0.25 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fasitibant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Dose: 0.25 mg fasitibant in 1 mL solution for IA injection single treatment course, consisting of 2 injections at 2-weeks intervall: 0.25 mg followed by 0.25 mg

    Arm title
    		 High dose
    Arm description
    		 Fasitibant 2x0.5 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fasitibant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Dose: 0.50 mg fasitibant in 1 mL solution for IA injection single treatment course, consisting of 2 injections at 2-weeks intervall: 0.50 mg followed by 0.50 mg

    Arm title
    		 Single high dose
    Arm description
    		 Fasitibant 1x0.5 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fasitibant
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Dose: 0.50 mg fasitibant in 1 mL solution for IA injection single treatment course, consisting of 2 injections at 2-weeks intervall: 0.50 mg followed by placebo

    Arm title
    		 Placebo
    Arm description
    		 2x placebo; single treatment course, consisting of 2 injections at 2-weeks intervall
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    Intra-articular injection of 2 doses of Placebo control at 2-week interval

    Number of subjects in period 1
    		Low dose Mid dose High dose Single high dose Placebo
    Started
    83
    88
    84
    84
    84
    Completed
    77
    80
    73
    80
    73
    Not completed
    6
    8
    11
    4
    11
         Consent withdrawn by subject
    6
    8
    11
    4
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Low dose
    Reporting group description
    		 Fasitibant 2x0.125 mg

    Reporting group title
    Mid dose
    Reporting group description
    		 Fasitibant 2x0.25 mg

    Reporting group title
    High dose
    Reporting group description
    		 Fasitibant 2x0.5 mg

    Reporting group title
    Single high dose
    Reporting group description
    		 Fasitibant 1x0.5 mg

    Reporting group title
    Placebo
    Reporting group description
    		 2x placebo; single treatment course, consisting of 2 injections at 2-weeks intervall

    Reporting group values
    		 Low dose Mid dose High dose Single high dose Placebo Total
    Number of subjects
    		 83 88 84 84 84 423
    Age categorical
    Units: Subjects
        Age ≥ 40
    		 83 88 84 84 84 423
    Age continuous
    Age
    Units: years
        arithmetic mean (standard deviation)
    		 66.7 ± 9.0 65.9 ± 9.5 65.1 ± 9.7 65.3 ± 8.7 65.1 ± 8.5 -
    Gender categorical
    Units: Subjects
        Female
    		 44 46 51 56 55 252
        Male
    		 39 42 33 28 29 171
    Radiographic Osteoarthritis severity
    Based on Kellgren & Lawrence radiologic scale criteria (Grade 1 to 4): narrowing of joint space osteophytic stuctures sclerosis deformity of bone contour
    Units: Subjects
        Grade 1
    		 0 0 0 0 0 0
        Grade 2
    		 52 45 44 41 42 224
        Grade 3
    		 31 43 40 42 42 198
        Grade 4
    		 0 0 0 0 0 0
        missing information
    		 0 0 0 1 0 1
    Duration of osteoarthritis symptoms
    Units: Years
        arithmetic mean (standard deviation)
    		 9.7 ± 9.2 8.0 ± 6.3 7.9 ± 6.6 8.2 ± 8.4 6.5 ± 6.4 -
    WOMAC VA 3.1 A score (Total pain)
    Western Ontario and McMaster Universities osteoarthritis index (WOMAC). The WOMAC VA 3.1 A score (total pain, range 0-500 mm) is the sum of VAS subscores (0-100 mm) attributed by the patient to each of the 5 questions referring to osteoarthritic pain experienced during the preceding 48 hours (pain domain). The higher is the WOMAC VA 3.1 A ore, the higher is the intensity of pain symptoms (0 = no pain ; 500 = extreme pain). A decrease of the WOMAC VA 3.1 A score following tratment administration indicates a reduction of pain symptom.
    Units: mm
        arithmetic mean (standard deviation)
    		 288 ± 80 282 ± 68 293 ± 73 283 ± 72 284 ± 79 -

    End points

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    End points reporting groups
    Reporting group title
    Low dose
    Reporting group description
    		 Fasitibant 2x0.125 mg

    Reporting group title
    Mid dose
    Reporting group description
    		 Fasitibant 2x0.25 mg

    Reporting group title
    High dose
    Reporting group description
    		 Fasitibant 2x0.5 mg

    Reporting group title
    Single high dose
    Reporting group description
    		 Fasitibant 1x0.5 mg

    Reporting group title
    Placebo
    Reporting group description
    		 2x placebo; single treatment course, consisting of 2 injections at 2-weeks intervall

    Primary: WOMAC VA 3.1 A Score (Total Pain)

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    End point title
    		 WOMAC VA 3.1 A Score (Total Pain)
    End point description
    The primary endpoint was the WOMAC VA 3.1 A sub score (total pain) decrease over the 3 weeks after first drug administrations compared with baseline (ITT population).
    End point type
    Primary
    End point timeframe
    over the 3 weeks after the first administration
    End point values
    		 Low dose Mid dose High dose Single high dose Placebo
    Number of subjects analysed
    83
    88
    83
    83
    84
    Units: mm
    arithmetic mean (standard deviation)
        1 week post dose
    -60 ± 84
    -58 ± 82
    -52 ± 92
    -67 ± 91
    -63 ± 103
        2 weeks post dose
    -69 ± 89
    -65 ± 81
    -71 ± 102
    -73 ± 96
    -75 ± 93
        3 weeks post dose
    -103 ± 107
    -99 ± 86
    -99 ± 104
    -103 ± 99
    -103 ± 112
    Statistical analysis title
    		 Statistical Analysis for primary endpoint
    Comparison groups
    Low dose v Mid dose v High dose v Single high dose v Placebo
    Number of subjects included in analysis
    421
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5263
    Method
    		 ANCOVA
    Confidence interval

    Secondary: WOMAC VA 3.1.B Score (Knee Stiffness)

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    End point title
    		 WOMAC VA 3.1.B Score (Knee Stiffness)
    End point description
    A decrease of the WOMAC VA 3.1 B score following treatment administration indicates a reduction of joint stiffness. The change at Week 13 from baseline is reported. WOMAC VA 3.1.B score(range 0-200) is the sum of VAS scores (0-100 mm)attributed by the patient to each of the 2 questions referring to joint stiffness experienced during the preceding 48 hours. The higher is the WOMAC VA 3.1 B score, the higher is joint stiffness (0 = no stiffness ; 200 = extreme stiffness).
    End point type
    Secondary
    End point timeframe
    up to 3 months after first dose
    End point values
    		 Low dose Mid dose High dose Single high dose Placebo
    Number of subjects analysed
    83
    87
    84
    83
    84
    Units: mm
    arithmetic mean (standard deviation)
        Baseline
    105.7 ± 47.36
    101.8 ± 39.7
    109.4 ± 46.21
    107.3 ± 43.3
    108.7 ± 47.67
        Week 13
    61.5 ± 52.2
    66.1 ± 47.4
    64.5 ± 50.1
    66.2 ± 49.3
    63.4 ± 51.3
    No statistical analyses for this end point

    Secondary: WOMAC VA 3.1. C Score (Function)

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    End point title
    		 WOMAC VA 3.1. C Score (Function)
    End point description
    A decrease of the WOMAC VA 3.1 C score following treatment administration indicates an improvement in performing daily activities. WOMAC VA 3.1.C scores at baseline and at Week 13 are reported. Knee function evaluated by WOMAC VA 3.1 C score (range 0-1700) is the sum of VAS scores (range 0-100 mm) attributed by the patient to each of 17 questions referring to difficulty in performing daily activities experienced during the preceding 48 hours. The higher is the WOMAC VA 3.1 C score, the higher is functional impairment in daily activities (0 = no difficulty ; 1700 = extreme difficulty).
    End point type
    Secondary
    End point timeframe
    up to 3 months after first dose
    End point values
    		 Low dose Mid dose High dose Single high dose Placebo
    Number of subjects analysed
    82
    88
    83
    82
    83
    Units: mm
    arithmetic mean (standard deviation)
        Baseline
    928.7 ± 336.2
    915.5 ± 285.2
    906.7 ± 318.19
    938.7 ± 300.63
    936.5 ± 343.8
        Week 13
    537.5 ± 415.9
    598.0 ± 396.9
    574.6 ± 407.0
    594.8 ± 444.3
    557.6 ± 389.0
    No statistical analyses for this end point

    Secondary: Percentage of Treatment Responders According to OMERACT-OARSI Responder Criteria

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    End point title
    		 Percentage of Treatment Responders According to OMERACT-OARSI Responder Criteria
    End point description
    Osteoarthritis Research Society International (OARSI). Response defined as: a decrease in WOMAC pain or physical-function score by 50% or more and by 20 or more points on the visual analogue scale OR if two of the following three findings are recorded: a decrease in the WOMAC pain score by 20% or more and by 10 or more points on the visual analogue scale; a decrease in the WOMAC physical-function score by 20% or more and by 10 or more points on the scale; an improvement in the score on the patient’s global assessment by 20% or more and by 10 or more points on the scale
    End point type
    Secondary
    End point timeframe
    up to 3 months after first dose
    End point values
    		 Low dose Mid dose High dose Single high dose Placebo
    Number of subjects analysed
    83
    88
    83
    83
    84
    Units: Percentage of patients
    number (not applicable)
        Week 1
    44.6
    35.6
    36.6
    41.5
    44.4
        Week 2
    46.3
    36.0
    37.0
    47.6
    53.8
        Week 3
    61.8
    67.5
    54.4
    57.3
    57.7
        Week 13
    64.2
    66.7
    59.8
    64.6
    53.6
    No statistical analyses for this end point

    Secondary: Patient Global Assessment

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    End point title
    		 Patient Global Assessment
    End point description
    Patient global assessment evaluated using a VAS scale score attributed by the patient (range 0-100 mm). Efficacy assessed as change at each time-point post-dosing (week 1, 2 ,3, 13) versus baseline (week 0). A decrease of patient global assessment score indicates an improvement of osteoarthritis symptoms.
    End point type
    Secondary
    End point timeframe
    up to 3 months after first dose
    End point values
    		 Low dose Mid dose High dose Single high dose Placebo
    Number of subjects analysed
    83
    88
    83
    83
    84
    Units: mm
    arithmetic mean (standard deviation)
        Week1
    -4.2 ± 21.8
    -3.3 ± 20.4
    0.9 ± 18.5
    -6.3 ± 23.6
    -7.8 ± 22.2
        Week 2
    -4.7 ± 19.6
    -0.4 ± 21.4
    -0.3 ± 20.6
    -7.4 ± 21.9
    -9.0 ± 24.6
        Week 3
    -8.4 ± 25.3
    -4.6 ± 21.3
    -6.4 ± 21.5
    -10.2 ± 24.7
    -11.7 ± 24.0
        Week 13
    -14.8 ± 26.4
    -7.5 ± 22.3
    -8.8 ± 23.6
    -11.4 ± 22.9
    -16.3 ± 28.8
    No statistical analyses for this end point

    Secondary: WOMAC VA 3.1A - Total Pain Score by Body Mass Index [BMI <= 25]

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    End point title
    		 WOMAC VA 3.1A - Total Pain Score by Body Mass Index [BMI <= 25]
    End point description
    Analysis in normal-weight population (BMI <= 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported. A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom.
    End point type
    Secondary
    End point timeframe
    over the 3 weeks after the first administration
    End point values
    		 Low dose Mid dose High dose Single high dose Placebo
    Number of subjects analysed
    9
    15
    6
    9
    12
    Units: mm
    arithmetic mean (standard deviation)
        1 week post dose 1
    -11.4 ± 53.91
    -72.4 ± 55.78
    -109.0 ± 91.97
    -109.0 ± 86.66
    2.7 ± 75.21
        2 weeks post dose 1
    9.2 ± 97.88
    -90.7 ± 70.94
    -99.2 ± 39.89
    -63.8 ± 90.05
    -31.2 ± 71.80
        3 weeks post dose 1
    -22.4 ± 100.02
    -110.7 ± 80.72
    -107.8 ± 46.16
    -112.9 ± 93.52
    -62.3 ± 83.43
    No statistical analyses for this end point

    Secondary: WOMAC VA 3.1A - Total Pain Score by Body Mass Index -[BMI > 25]

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    End point title
    		 WOMAC VA 3.1A - Total Pain Score by Body Mass Index -[BMI > 25]
    End point description
    Analysis in over-weight population (BMI > 25) of the WOMAC VA 3.1A score (range 0-500 mm) is reported. A decrease of the WOMAC VA 3.1 A score following treatment administration indicates a reduction of pain symptom
    End point type
    Secondary
    End point timeframe
    over the 3 weeks after the first administration
    End point values
    		 Low dose Mid dose High dose Single high dose Placebo
    Number of subjects analysed
    29
    36
    38
    30
    28
    Units: mm
    arithmetic mean (standard deviation)
        1 week post dose 1
    -76.5 ± 81.73
    -62.9 ± 81.14
    -56.4 ± 88.08
    -67.4 ± 86.99
    -58.0 ± 70.92
        2 weeks post dose 1
    -88.2 ± 83.18
    -78.2 ± 75.67
    -81.5 ± 105.08
    -81.6 ± 90.11
    -83.9 ± 72.71
        3 weeks post dose 1
    -103.4 ± 95.6
    -122.1 ± 69.96
    -114.1 ± 106.00
    -99.6 ± 83.74
    -103.3 ± 85.26
    No statistical analyses for this end point

    Secondary: Adverse Event Reports

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    End point title
    		 Adverse Event Reports
    End point description
    Incidence of spontaneously reported adverse events
    End point type
    Secondary
    End point timeframe
    up to 4 months after screening
    End point values
    		 Low dose Mid dose High dose Single high dose Placebo
    Number of subjects analysed
    83
    88
    83
    83
    84
    Units: Subjects
        Non-serious adverse events
    31
    38
    36
    28
    33
        Serious adverse events
    1
    2
    3
    3
    2
        Blood / Lymph system
    0
    0
    0
    1
    0
        Cardiac disorders
    2
    3
    1
    2
    1
        Eye disorders
    0
    0
    0
    1
    0
        Gastrointestinal disorders
    5
    3
    2
    2
    2
        General / administration site conditions
    3
    4
    6
    3
    3
        Infections / infestations
    11
    11
    10
    10
    10
        Injury / poisoning / procedural complications
    3
    4
    5
    2
    3
        Investigations
    2
    3
    3
    2
    3
        Metabolism and nutrition disorders
    1
    0
    0
    0
    2
        Musculoskeletal and connective tissue disorders
    6
    11
    11
    10
    12
        Nervous system disorders
    6
    3
    5
    3
    3
        Psychiatric disorders
    1
    0
    2
    0
    0
        Renal and Urinary disorders
    0
    0
    0
    0
    2
        Respiratory, thoracic, and mediastinal disorders
    0
    1
    0
    0
    0
        Skin and subcutaneous tissue disorders
    1
    0
    1
    1
    1
        Surgical and medical procedures
    1
    0
    1
    1
    1
        Vascular disorders
    4
    4
    2
    4
    2
        Social circumstances
    0
    1
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Clinically Significant Abnormal Laboratory Tests

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    End point title
    		 Clinically Significant Abnormal Laboratory Tests
    End point description
    Percentage of patients with Abnormal Laboratory Tests judged Clinically Significant by Investigators. The following hematochemical and urinary parameters were analysed: Red Blood Cells Count, Haematocrit, Haemoglobin, Platelets, MCV, MCH, MCHC, White Blood Cells, Sodium, Chloride, Potassium, Total calcium, AST (SGOT), ALT (SGPT), GGT, Alkaline phosphatase, Total Bilirubin, Direct Bilirubin, Creatinine, BUN, CPK, LDH, Glucose, Total proteins, Albumin.
    End point type
    Secondary
    End point timeframe
    up to 4 months from screening
    End point values
    		 Low dose Mid dose High dose Single high dose Placebo
    Number of subjects analysed
    83
    88
    84
    84
    84
    Units: Subjects
    number (not applicable)
        Blood GGT
    0
    0
    1
    0
    1
        Blood Alkaline Phophatase
    0
    0
    1
    0
    0
        Blood Total Bilirubin
    0
    0
    1
    0
    0
        Blood Creatinine
    0
    1
    0
    0
    0
        Blood Glucose
    0
    0
    0
    1
    1
        Blood Potassium
    0
    0
    1
    0
    1
        Blood Sodium
    0
    0
    0
    0
    1
        Blood Fibrin D dimer
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Four months of safety observation
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Low dose
    Reporting group description
    		 Fasitibant 2x0.125 mg

    Reporting group title
    Mid dose
    Reporting group description
    		 Fasitibant 2x0.25 mg

    Reporting group title
    High dose
    Reporting group description
    		 Fasitibant 2x0.5 mg

    Reporting group title
    Single high dose
    Reporting group description
    		 Fasitibant 1x0.5 mg

    Reporting group title
    Placebo
    Reporting group description
    		 2x placebo; single treatment course, consisting of 2 injections at 2-weeks intervall

    Serious adverse events
    		 Low dose Mid dose High dose Single high dose Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 83 (1.20%)
    2 / 88 (2.27%)
    3 / 83 (3.61%)
    3 / 83 (3.61%)
    2 / 84 (2.38%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Joint dislocation
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 88 (0.00%)
    1 / 83 (1.20%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    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
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 88 (1.14%)
    0 / 83 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    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
    Supraventricular-tachycardia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 88 (0.00%)
    0 / 83 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 88 (1.14%)
    0 / 83 (0.00%)
    0 / 83 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Knee operation
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 88 (0.00%)
    0 / 83 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatectomy
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 88 (0.00%)
    0 / 83 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 88 (0.00%)
    0 / 83 (0.00%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 88 (0.00%)
    1 / 83 (1.20%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    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
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 88 (0.00%)
    0 / 83 (0.00%)
    0 / 83 (0.00%)
    1 / 84 (1.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Uretic stenosis
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 88 (0.00%)
    0 / 83 (0.00%)
    1 / 83 (1.20%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureterocele
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 88 (0.00%)
    1 / 83 (1.20%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
         occurrences causally related to treatment / all
    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
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Low dose Mid dose High dose Single high dose Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 83 (20.48%)
    18 / 88 (20.45%)
    21 / 83 (25.30%)
    15 / 83 (18.07%)
    16 / 84 (19.05%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 83 (2.41%)
    1 / 88 (1.14%)
    3 / 83 (3.61%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    2
    1
    3
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 83 (2.41%)
    2 / 88 (2.27%)
    0 / 83 (0.00%)
    4 / 83 (4.82%)
    2 / 84 (2.38%)
         occurrences all number
    2
    2
    0
    4
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 83 (3.61%)
    1 / 88 (1.14%)
    1 / 83 (1.20%)
    0 / 83 (0.00%)
    2 / 84 (2.38%)
         occurrences all number
    3
    1
    1
    0
    2
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    2 / 83 (2.41%)
    3 / 88 (3.41%)
    3 / 83 (3.61%)
    2 / 83 (2.41%)
    1 / 84 (1.19%)
         occurrences all number
    2
    3
    3
    2
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 83 (2.41%)
    5 / 88 (5.68%)
    7 / 83 (8.43%)
    6 / 83 (7.23%)
    3 / 84 (3.57%)
         occurrences all number
    4
    5
    7
    7
    3
    Back pain
         subjects affected / exposed
    0 / 83 (0.00%)
    3 / 88 (3.41%)
    0 / 83 (0.00%)
    2 / 83 (2.41%)
    3 / 84 (3.57%)
         occurrences all number
    0
    3
    0
    2
    3
    Osteoarthritis
         subjects affected / exposed
    1 / 83 (1.20%)
    3 / 88 (3.41%)
    2 / 83 (2.41%)
    0 / 83 (0.00%)
    0 / 84 (0.00%)
         occurrences all number
    1
    3
    2
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 83 (6.02%)
    5 / 88 (5.68%)
    4 / 83 (4.82%)
    4 / 83 (4.82%)
    5 / 84 (5.95%)
         occurrences all number
    5
    5
    4
    5
    6
    Urinary tract infection
         subjects affected / exposed
    1 / 83 (1.20%)
    1 / 88 (1.14%)
    3 / 83 (3.61%)
    0 / 83 (0.00%)
    2 / 84 (2.38%)
         occurrences all number
    1
    2
    3
    0
    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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