A Study to Evaluate and Compare the Efficacy and Safety of Mirabegron 25 mg ER tablet and 50 mg ER tablet with Tolterodine 4 mg ER tablet in Patients with Overactive Bladder.
- Conditions
- Health Condition 1: null- Patients having symptoms of OAB
- Registration Number
- CTRI/2016/04/006790
- Lead Sponsor
- MSN Laboratories Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 312
1)Female/Male patients of age between 18-55 years
2)Patients having symptoms of OAB (urinary frequency and urgency with or without urge incontinence) for >= 3 months
3)Patients diagnosed with OAB based on scores >=1 in the URGENCY Questionnaire.
4)Patients diagnosed with OAB based on scores >=3 in the OABSS Questionnaire
5)Patients not treated with anticholinergics
6)Patients or patientâ??s legally acceptable representative willing to sign the Informed Consent Form.
7)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
8)Washout period of 2 weeks when the patient is receiving anticholinergics
1)Patients with urinary tract infections
2)Patients with renal calculi
3)Patients with renal tumors , bladder cancer or prostate cancer
4)Patients with urinary retention
5)Residual urine volume >=100 mL (determined by abdominal sonography)
6)Patients with reduced gastrointestinal motility
7)Patients with myasthenia gravis
8)Patients with narrow angle glaucoma
9)Patients with occluded pyloric region or paralytic ileus gastric and intestinal atony
10)Patients with contraindications to anticholinergic drugs
11)Clinically relevant or unstable cardiovascular diseases
12)Type 1 or poorly controlled type 2 diabetes mellitus (hemoglobin A1c: >=9%).
13)Patients with neurologic disorders (e.g., multiple sclerosis, disk herniation, stroke, or diabetes) or previous urogenital operations (e.g., radical prostatectomy, transurethral resection)
14)History of drug or alcohol abuse
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.
16)Subject has undergone administration of any investigational drug within 30 days of study initiation.
17)Subject 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 1)Changes from baseline to end of treatment visit in mean number of incontinence episodes per 24 hours <br/ ><br>2)Changes from baseline to end of treatment visit in mean number of micturitions per 24 hoursTimepoint: Day 1 Day 30 Day 60 and Day 90
- Secondary Outcome Measures
Name Time Method 1)Changes in OABSS components from baseline to end-of-study (daytime frequency, nighttime frequency, urgency, and urgency incontinence) <br/ ><br>2)Percent responders to treatment and percent patients requiring rescue medications. <br/ ><br>3)Tolerability and changes in serum biochemistry post treatment as compared to baseline <br/ ><br>Timepoint: Day 1 Day 30 Day 60 Day 90