A Clinical Study to Assess the Effectiveness and Side effects of Mirabegron PlusSolifenacin in Patients with Urinary Frequency and Urgency
- Conditions
- Health Condition 1: N328- Other specified disorders of bladder
- Registration Number
- CTRI/2021/01/030395
- Lead Sponsor
- Hetero Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Adult male or female patients with age of 18 to 65 years
2. Patients who are treatment naïve or received prior anticholinergics medication
3. Patients with an average frequency of micturition of 8 or more times per 24-hour
4. Patients with an average episode of urgency with or without incontinence of one or more times per 24-hours period
1. Hypersensitive history to mirabegron, solifenacin, other antimuscarinic, other beta-adrenoreceptor (Ã?-AR) agonists
2. Currently have a clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular,
gastrointestinal and/or other urological disorder
3. Patients with stress urinary incontinence as a predominant symptom
4. Patients with bladder outflow obstruction, urinary tract infection, urinary stones, and/or interstitial cystitis or chronic inflammation
due to bladder pain syndrome or with a history of recurrent urinary tract infections
5. Patients with indwelling catheter or practicing intermittent self-catheterization
6. Patients with history of diabetic neuropathy
7. Currently participating in another investigational study or has participated in an investigational study within 90 days prior to
randomization
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in mean number of micturitions per 24 hoursTimepoint: Baseline and End of Week 12
- Secondary Outcome Measures
Name Time Method Change in mean number of incontinence episodes per 24 hours <br/ ><br>Timepoint: Baseline, Week 4, Week 8 and Week 12;Change in mean number of micturitions per 24 hoursTimepoint: Baseline, Week 4 and Week 8;Change in mean number of urgency episodes per 24 hoursTimepoint: Baseline, Week 4, Week 8 and Week 12;Change in OABSS scoreTimepoint: Baseline, Week 4, Week 8 and <br/ ><br>Week 12;Treatment emergent clinical & laboratory adverse events <br/ ><br>(TEAEs)Timepoint: All Visits