A comparative Phase III clinical trial to evaluate the efficacy and safety of FDC of Mirabegron 25mg/50mg (ER) plus Solifenacin succinate 5mg/5mg tablet versus Mirabegron 25mg/50mg tablet, Solifenacin succinate 5mg tablet in subjects diagnosed with Overactive bladder.
- Conditions
- Health Condition 1: N33- Bladder disorders in diseases classified elsewhere
- Registration Number
- CTRI/2019/08/020935
- Lead Sponsor
- Windlas Biotech Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 176
Subjects who meet the following criteria are eligible for inclusion in
the study:
1.Patients or patientâ??s legally acceptable representative willing to sign the Informed Consent Form.â?¨
2.Patients willing and able to participate in all aspects of the core study, including use of oral medication, completion of subjective evaluations, and compliance with protocol requirements.â?¨
3.Female and Male (both) patients of age >=18 to <=65years.â?¨
4.Patients having symptoms of OAB (urinary frequency and urgency with or without urge incontinence) for 3 months.â?¨
5.Patients diagnosed with OAB based on scores 1 in the URGENCY Questionnaire.â?¨
6.Patients diagnosed with OAB based on scores 3 in the OABSS Questionnaire.â?¨
7.Patients not treated with anticholinergics.â?¨
8.Washout period of 15 days when the patient is receiving anticholinergics.
1.Patients with urinary tract infections.â?¨
2.Patients with renal calculi.â?¨
3.Patients with renal tumours , bladder cancer or prostate cancer
4.Patients with urinary retention.
5.Residual urine volume >100 mL (determined by abdominal sonography)â?¨
6.Patients with reduced gastrointestinal motility.â?¨
7.Patients with myasthenia gravis.â?¨
8.Patients with narrow angle glaucoma.â?¨
9.Patients with occluded pyloric region or paralytic ileus gastric and intestinal atony.â?¨
10.Patients with contraindications to anticholinergic drugs.
11.Clinically relevant or unstable cardiovascular diseases or hypertensive patient diagnosed with systolic blood pressure >= 180mm Hg and/or diastolic blood pressure >= 110mm Hg). â?¨
12.Type 1 or poorly controlled type 2 diabetes mellitus (haemoglobin A1c: >9%).â?¨
13.Patients with neurologic disorders (e.g., multiple sclerosis, disk herniation, stroke, or diabetes) or previous urogenital operations (e.g., radical prostatectomy, transurethral resection).â?¨
14.Patients with history of drug or alcohol abuse.â?¨
15.Those with any medical condition judged by investigators to possibly jeopardize the evaluation of efficacy and safety of therapy were excluded from the study.â?¨
16.Patient has undergone administration of any investigational drug within 30 days of study initiation.â?¨
17.Patient has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method