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    Clinical Trial Results:
    A Multicentre, Placebo Controlled, Randomised, Double-blind, Dose Ranging Study of SVT-40776 0.05 mg, 0.1 mg, 0.2 mg, Tolterodine 4 mg and Placebo Daily Doses for 4 Weeks in Patients Suffering from Overactive Bladder Syndrome

    Summary
    EudraCT number
    		 2006-001378-26
    Trial protocol
    		 DE   NL   CZ   HU   ES  
    Global end of trial date
    12 Sep 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jan 2016
    First version publication date
    31 Jan 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    40776ORII/05IA01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00507169
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Laboratorios SALVAT, S.A.
    Sponsor organisation address
    Gall, 30-36, Esplugues de Llobregat, Spain, 08950
    Public contact
    Medical Department, Laboratorios SALVAT, S.A., 34 933946400, clinicaltrials@salvatbiotech.com
    Scientific contact
    Medical Director, Laboratorios SALVAT, S.A., 34 933946470, ejimenezv@salvatbiotech.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
    12 Mar 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Sep 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the dose-response relationship of SVT-40776 on efficacy
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Sep 2006
    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: 3
    Country: Number of subjects enrolled
    Czech Republic: 99
    Country: Number of subjects enrolled
    Germany: 35
    Country: Number of subjects enrolled
    Hungary: 43
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    New Zealand: 27
    Country: Number of subjects enrolled
    Poland: 65
    Country: Number of subjects enrolled
    Russian Federation: 81
    Country: Number of subjects enrolled
    South Africa: 60
    Country: Number of subjects enrolled
    United States: 28
    Worldwide total number of subjects
    448
    EEA total number of subjects
    249
    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)
    308
    From 65 to 84 years
    140
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment period was from 18th September 2006 to 12th September 2007 (Europe, USA, South Africa, Australia and New Zealand)

    Pre-assignment
    Screening details
    		 Patients between 18 and 80 years suffering from OAB based on three cardinals symptoms (urgency with or without urge incontinence, usually accompanied by frecuency or nocturia) for at least six months prior to inclusion.

    Pre-assignment period milestones
    Number of subjects started
    		 669 [1]
    Number of subjects completed
    		 448

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screen failure: 221
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of screening patients (pre-assignement period) were 669 but only 448 were included in period 1 (Run-in period)
    Period 1
    Period 1 title
    Run-in period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    All patients took placebo but they were not aware about of what treatment they were recieving.

    Arms
    Arm title
    		 Placebo
    Arm description
    		 Washout period
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    All patients self-administered a single placebo capsule each day for fourteen consecutive days, in the morning with 200ml (a glass) of water, at least 30 minutes before the first meal.

    Number of subjects in period 1
    		Placebo
    Started
    448
    Completed
    352
    Not completed
    96
         Consent withdrawn by subject
    6
         Physician decision
    4
         Adverse event, non-fatal
    8
         Enrolment failure
    67
         Lost to follow-up
    1
         Sponsor decition
    5
         Protocol deviation
    5
    Period 2
    Period 2 title
    Double blind
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The patients were randomized using IVRS. All study medication products (test and comparators) had the same packaging and labels, and the boxes in which the study medication was packaged, shipped, and dispensed were identical in appearance.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SVT-40776 0.2mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    SVT-40776
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Each patient self-administered a single capsule each day in the morning with 200ml (a glass) of water, at least 30 minutes before the first meal for 28 consecutive days.

    Arm title
    		 SVT-40776 0.1mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    SVT-40776
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Each patient self-administered a single capsule each day in the morning with 200ml (a glass) of water, at least 30 minutes before the first meal for 28 consecutive days.

    Arm title
    		 SVT-40776 0.05mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    SVT-40776
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Each patient self-administered a single capsule each day in the morning with 200ml (a glass) of water, at least 30 minutes before the first meal for 28 consecutive days.

    Arm title
    		 Tolterodine 4mg
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tolterodine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Each patient self-administered a single capsule each day in the morning with 200ml (a glass) of water, at least 30 minutes before the first meal for 28 consecutive days.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Each patient self-administered a single capsule each day in the morning with 200ml (a glass) of water, at least 30 minutes before the first meal for 28 consecutive days.

    Number of subjects in period 2
    		SVT-40776 0.2mg SVT-40776 0.1mg SVT-40776 0.05mg Tolterodine 4mg Placebo
    Started
    69
    64
    78
    67
    74
    Completed
    65
    63
    72
    62
    71
    Not completed
    4
    1
    6
    5
    3
         Consent withdrawn by subject
    2
    -
    -
    -
    1
         Adverse event, non-fatal
    -
    -
    2
    2
    -
         Sponsor decision
    2
    -
    2
    1
    1
         Lost to follow-up
    -
    -
    -
    -
    1
         Protocol deviation
    -
    1
    2
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Washout period

    Reporting group values
    		 Placebo Total
    Number of subjects
    		 448 448
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 308 308
        From 65-84 years
    		 140 140
    Age continuous
    Units: years
        median (full range (min-max))
    		 57 (20 to 79) -
    Gender categorical
    Units: Subjects
        Female
    		 369 369
        Male
    		 79 79

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Washout period
    Reporting group title
    SVT-40776 0.2mg
    Reporting group description
    		 -

    Reporting group title
    SVT-40776 0.1mg
    Reporting group description
    		 -

    Reporting group title
    SVT-40776 0.05mg
    Reporting group description
    		 -

    Reporting group title
    Tolterodine 4mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Change in number of micturitions per 24hours

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    End point title
    		 Change in number of micturitions per 24hours
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to the end of the double blind treatment period.
    End point values
    		 SVT-40776 0.2mg SVT-40776 0.1mg SVT-40776 0.05mg Tolterodine 4mg Placebo
    Number of subjects analysed
    65
    63
    70
    64
    70
    Units: micturitions
        median (full range (min-max))
    -2.638 (-10.98 to 1.74)
    -2.274 (-19.78 to 10.33)
    -1.903 (-10.03 to 40.86)
    -2.636 (-10.06 to 6.16)
    -1.928 (-8.51 to 5.36)
    Statistical analysis title
    		 Change in the number of micturitions
    Statistical analysis description
    Change in the number of micturitions per 24h from baseline to the end of the double blind treatment period
    Comparison groups
    SVT-40776 0.1mg v SVT-40776 0.2mg v SVT-40776 0.05mg v Tolterodine 4mg v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - A hierarchical test procedure was performed. Comparison of tolterodine with placebo was a separate analysis performed exactly as for the primary analysis, as was a last observation carried forward (LOCF) analysis (carrying forward the Visit 2 value if the Visit 3 value was missing), for all analyses.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Double blind period
    Adverse event reporting additional description
    Related Treatment Emergent Adverse Events
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    SVT-40776 0.2mg
    Reporting group description
    		 -

    Reporting group title
    SVT-40776 0.1mg
    Reporting group description
    		 -

    Reporting group title
    SVT-40776 0.05mg
    Reporting group description
    		 -

    Reporting group title
    Tolterodine 4mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 SVT-40776 0.2mg SVT-40776 0.1mg SVT-40776 0.05mg Tolterodine 4mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 69 (0.00%)
    0 / 64 (0.00%)
    0 / 78 (0.00%)
    0 / 67 (0.00%)
    0 / 74 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 SVT-40776 0.2mg SVT-40776 0.1mg SVT-40776 0.05mg Tolterodine 4mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 69 (18.84%)
    6 / 64 (9.38%)
    15 / 78 (19.23%)
    14 / 67 (20.90%)
    24 / 74 (32.43%)
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 64 (1.56%)
    0 / 78 (0.00%)
    0 / 67 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood glucose increased
         subjects affected / exposed
    2 / 69 (2.90%)
    0 / 64 (0.00%)
    0 / 78 (0.00%)
    0 / 67 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Blood potassium increased
         subjects affected / exposed
    0 / 69 (0.00%)
    0 / 64 (0.00%)
    0 / 78 (0.00%)
    0 / 67 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 69 (1.45%)
    2 / 64 (3.13%)
    0 / 78 (0.00%)
    2 / 67 (2.99%)
    1 / 74 (1.35%)
         occurrences all number
    1
    2
    0
    2
    1
    Headache
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 64 (0.00%)
    0 / 78 (0.00%)
    2 / 67 (2.99%)
    1 / 74 (1.35%)
         occurrences all number
    1
    0
    0
    3
    1
    Somnolence
         subjects affected / exposed
    1 / 69 (1.45%)
    1 / 64 (1.56%)
    0 / 78 (0.00%)
    0 / 67 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 69 (0.00%)
    0 / 64 (0.00%)
    0 / 78 (0.00%)
    0 / 67 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    0
    0
    1
    Chest discomfort
         subjects affected / exposed
    0 / 69 (0.00%)
    0 / 64 (0.00%)
    0 / 78 (0.00%)
    1 / 67 (1.49%)
    0 / 74 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Thirst
         subjects affected / exposed
    0 / 69 (0.00%)
    0 / 64 (0.00%)
    0 / 78 (0.00%)
    0 / 67 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    0
    0
    1
    Eye disorders
    Eyelid oedema
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 64 (0.00%)
    0 / 78 (0.00%)
    0 / 67 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Eyelids pruritus
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 64 (0.00%)
    0 / 78 (0.00%)
    0 / 67 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    1 / 69 (1.45%)
    1 / 64 (1.56%)
    1 / 78 (1.28%)
    1 / 67 (1.49%)
    0 / 74 (0.00%)
         occurrences all number
    1
    1
    1
    1
    0
    Eye pain
         subjects affected / exposed
    0 / 69 (0.00%)
    0 / 64 (0.00%)
    0 / 78 (0.00%)
    1 / 67 (1.49%)
    0 / 74 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 64 (0.00%)
    1 / 78 (1.28%)
    0 / 67 (0.00%)
    2 / 74 (2.70%)
         occurrences all number
    1
    0
    2
    0
    4
    Dry mouth
         subjects affected / exposed
    8 / 69 (11.59%)
    3 / 64 (4.69%)
    9 / 78 (11.54%)
    6 / 67 (8.96%)
    5 / 74 (6.76%)
         occurrences all number
    8
    3
    10
    6
    5
    Dyspepsia
         subjects affected / exposed
    0 / 69 (0.00%)
    0 / 64 (0.00%)
    1 / 78 (1.28%)
    0 / 67 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 64 (1.56%)
    0 / 78 (0.00%)
    1 / 67 (1.49%)
    0 / 74 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Mouth ulceration
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 64 (0.00%)
    0 / 78 (0.00%)
    0 / 67 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 64 (1.56%)
    0 / 78 (0.00%)
    0 / 67 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 64 (1.56%)
    0 / 78 (0.00%)
    0 / 67 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 69 (0.00%)
    0 / 64 (0.00%)
    0 / 78 (0.00%)
    0 / 67 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    0
    0
    1
    Nasal dryness
         subjects affected / exposed
    0 / 69 (0.00%)
    0 / 64 (0.00%)
    1 / 78 (1.28%)
    0 / 67 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    0
    1
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 69 (0.00%)
    0 / 64 (0.00%)
    1 / 78 (1.28%)
    0 / 67 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Eczema
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 64 (1.56%)
    0 / 78 (0.00%)
    0 / 67 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 69 (0.00%)
    0 / 64 (0.00%)
    0 / 78 (0.00%)
    1 / 67 (1.49%)
    0 / 74 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 69 (0.00%)
    0 / 64 (0.00%)
    1 / 78 (1.28%)
    1 / 67 (1.49%)
    0 / 74 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    Rash
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 64 (1.56%)
    0 / 78 (0.00%)
    0 / 67 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 69 (0.00%)
    0 / 64 (0.00%)
    0 / 78 (0.00%)
    1 / 67 (1.49%)
    0 / 74 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 69 (0.00%)
    0 / 64 (0.00%)
    1 / 78 (1.28%)
    0 / 67 (0.00%)
    0 / 74 (0.00%)
         occurrences all number
    0
    0
    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
    22 Nov 2006
    To clarify inclusion/exclusion criteria and procedures, and modify the storage temperature of study medication.

    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
    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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