A clinical Study to Evaluate the Efficacy and Safety of Mirabegron in Indian Adult Patients with Symptoms of Overactive Bladder
- Conditions
- Health Condition 1: null- Adult Patients with Symptoms of Overactive BladderHealth Condition 2: N328- Other specified disorders of bladder
- Registration Number
- CTRI/2016/10/007409
- Lead Sponsor
- Hetero Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Adult male or female patients with age of 18 to 55 years and willing to give written, signed, and dated informed consent to participate in the study
2. Patients with symptoms of overactive bladder (urinary frequency and urgency with or without urge incontinence) for at least 12 weeks before the screening
3. Patients who are treatment naïve or received prior anticholinergics medication. Patients who are on anticholinergics medication must undergo 2 weeks of wash-out period
4. Patients capable of walking to the toilet without assistance and measuring the urine volume by him/herself
5. Patients with an average frequency of micturition of 8 or more times per 24-hour period during the period of 3 day micturition dairy before randomization
6. Patients with an average episode of urgency or urge incontinence of one or more times per 24-hours period during the period of 3 day micturition dairy before randomization
7. Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study
8. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator
1. Hypersensitive to mirabegron, tolterodine, other anticholinergics, other beta-adrenoreceptor (ß-AR) agonists, or lactose or any of the other inactive ingredients
2. Patients using prohibited medications (CYP2D6 substrates with a narrow therapeutic index [thioridazine, flecainide, and propafenone], strong CYP3A4 inhibitors, antibiotics/antivirals, antifungals, antiarrhythmics, or cisapride, metoclopramide, or nefazodone).
3. Currently have a clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal and/or other urological disorder
4. Patients with clinically significant abnormal electrocardiogram (ECG)
5. Patients with stress urinary incontinence as a predominant symptom
6. Patients with transient symptoms suspected for overactive bladder
7. Patients complicated with bladder outflow obstruction, urinary tract infection, urinary stones, and/or interstitial cystitis or with a historical condition of recurrent urinary tract infection
8. Patients complicated with bladder tumor/prostatic tumor or with the historical condition
9. Patients confirmed to have a post void residual volume of more than or equal to 100ml or with a clinically significant lower urinary tract obstructive disease
10. Patients with an average total daily urine volume >3000 mL as recorded in the 3 day micturition dairy before randomization
11. Patients with indwelling catheter or practicing intermittent self-catheterization
12. Patients with radiotherapy influencing urinary tract functions, or thermotherapy for benign prostatic hyperplasia
13. Patients with surgical therapy which may influence urinary tract functions within 24 weeks before the study
14. Patients receiving non-drug treatment including electro-stimulation therapy
15. Patients with diabetic neuropathy
16. Patients with uncontrolled narrow-angle glaucoma
17. Patients with uncontrolled hypertension (indicated by sitting SBP =180mmHg or DBP =110mmHg)
18. Subject with a pulse rate =110bpm or <50 bpm
19. History of drug or alcohol abuse
20. Currently participating in another investigational study or has participated in an investigational study within 90 days prior to randomization
21. Patients with the current/past infections such as tuberculosis, herpes and/or patients with immune system disorders like HIV and SLE
22. Any other disease state which could interfere with trial participation or trial evaluation as per investigator’s discretion
23. Women of child-bearing potential, pregnant or lactating women, women practicing contraception by other than barrier methods or intending to donate eggs within the projected duration of the study and post-study follow-up period
24.The physician is of the opinion that patient’s trial medications would put the patient at risk
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method