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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 April 2022 |
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Main ID: |
EUCTR2009-014049-10-FR |
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Date of registration:
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08/10/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Exploratory study of besipirdine efficacy and safety in male patients with persistent stress urinary incontinence after radical prostatectomy
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Scientific title:
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Exploratory study of besipirdine efficacy and safety in male patients with persistent stress urinary incontinence after radical prostatectomy |
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Date of first enrolment:
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27/11/2009 |
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Target sample size:
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25 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014049-10 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: yes
Double blind: yes
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Male out patients,
- Aged =40 and = 80 years,
- Stress urinary incontinence following radical prostatectomy (for prostate cancer) persistent for at least 12 months and stable for at least 6 months prior to selection visit,
- Using pads for Stress Urinary Incontinence,
- Pad weight between 10 and 75 g at 24-hour home Pad Test (average weight of the 24-hour home pad test performed for 3 consecutive days within the 7 days prior to the inclusion visit),
- Life expectancy of at least 6 months
- Having signed his informed consent form,
- Patient able to fill in self-questionnaires,
- Affiliated to a social security system, or is a beneficiary
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
- Mixed incontinence with predominant Overactive Bladder
- Urinary incontinence prior to prostatectomy,
- Neurological pathology that affects the lower urinary tract (Spinal cord lesions, multiple sclerosis, Parkinson’s disease, Diabetes Mellitus ….),
- Adult nocturnal enuresis,
- Recent urethral pathology (<6 months) such as fistula, diverticulosis, stenosis,
- Recent radiotherapy (<6 months)
- Absence of voluntary micturition (permanent leakage),
- Polyuria (urinary volume > 3 l/day),
- Recurrent urinary infection (every 6 months or less),
- Perineal reeducation on-going or stopped less than 3 months prior to selection,
- Bad compliance in patient diary completion during the run-in period (i.e. data reported less than 3 consecutive days),
- Bradycardia (resting HR<50 bpm),
- Arterial Hypertension (defined as SBP>140 mmHg and/or DBP>90 mmHg or uncontrolled and not stable),
- Any clinically significant cardiac arrhythmia or conduction disturbance,
- Evidence of active liver disease (levels of AST or ALT> 2 times the upper normal laboratory value and/or alkaline phosphatase > 1,5 times the upper normal laboratory value)
- Intake of any treatment known to have an activity on urethral sphincter or detrusor (e.g. anticholinergic, antidepressants, a-stimulants…)
- Recent start or dosage modification of anti-androgen treatment (< 6 months)
- Patient known to be non responder to NSRI,
- Bad compliance to study drug intake during the run-in period (i.e. less than 70%),
- Alcohol or drug abuse or dependence,
- Is a family member or work associate (secretary, nurse, technician,…) of the Investigator,
- Has participated in another clinical trial within the last 3 month(s), has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial,
- Mentally unable to understand the nature, objectives and possible consequences of the trial; or refusing to subject himself to its constraints,
- Has forfeited his freedom by administrative or legal award or is under guardianship.
- Known lactose intolerance,
Age minimum:
Age maximum:
Gender:
Female: no
Male: yes
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Health Condition(s) or Problem(s) studied
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Persistant stress urinary incontinence further to radical prostatectomy
MedDRA version: 12.0
Level: LLT
Classification code 10046543
Term: Urinary incontinence
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Intervention(s)
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Product Name: besipirdine hydrochloride
Product Code: HP749
Pharmaceutical Form: Capsule*
INN or Proposed INN: besipirdine hydrochloride
Current Sponsor code: HP749
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): Efficacy : Leakage volume at 24-hour home Pad test (dry, responder rate, mean volume)Patient Global Impression (PGI) of severity and of change.
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Main Objective: To assess the clinical efficacy of besipirdine (20 mg b.i.d.) compared to placebo in male patients with persistent stress urinary incontinence further to radical prostatectomy
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Secondary Objective: To assess the tolerability of besipirdine (20 mg b.i.d.) compared to placebo in male patients with persistent stress urinary incontinence further to radical prostatectomy
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Secondary ID(s)
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HP0749GE201
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 10/11/2009
Contact:
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