Efficacy study of HP749, 20mg versus placebo in patients with OAB- UG058-0204
- Conditions
- Over Active BladdersRenal and Urogenital - Other renal and urogenital disorders
- Registration Number
- ACTRN12605000584639
- Lead Sponsor
- roGene SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 210
History of at least 6 months of OAB symptoms, defined as at least 8 micturitions/day, one urgency with or without incontinence episode (at least one/day) and nocturia (to wake at night > 1 time to void). Patients without medication for OAB, or with ineffective and/or unsatisfactory medication for OAB or with a history of ineffective and/or unsatisfactory medication for OAB are included in the trial (wash-out of 2 weeks is mandatory before base-line period and urodynamic examination). Prerequisites for inclusion are no previous bladder training or no current bladder training if started less than one month prior to the trial. Patients with polyuria, urodynamic stress incontinence, renal disease, or bladder outlet obstruction are excluded from the trial, as are patients having any other disease or condition (including neurological disease that could be linked to OAB symptoms) making them unsuitable for participating to the trial.
No exclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of frequency as a change (from baseline to end of the treatment) in mean number of micturitions per 24h.[]
- Secondary Outcome Measures
Name Time Method The proportion of patients cured at week 12 (frequency less than 8 micturitions per day) in the 20mg twice-daily HP749 arm will be compared to the placebo arm.[];Evaluation of urodynamic efficacy, in the subpopulation of patients with urodynamic abnormal parameters.[At baseline.];Safety evaluationine.[]