Health Condition 1: null- Adult Patients with Symptoms of Overactive Bladder Health Condition 2: N328- Other specified disorders of bladder
Conditions
Interventions
Intervention1: Mirabegron 25 mg and 50 mg: A. Mirabegron 25 mg extended release tablet manufactured by Hetero orally once daily for 12 weeks
B. Mirabegron 50 mg extended release tablet manufactured by
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to end of treatment (Week 12) in mean number of micturitions per 24 hoursTimepoint: Baseline and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to end of treatment (Week 12) in mean volume voided per micturitionTimepoint: Baseline and Week 12;Change from baseline to Week 4, Week 8 and end of treatment (Week 12) in domain score of QOL scores as assessed by King’s Health QuestionnaireTimepoint: Baseline, Week 4, Week 8 and Week 12;Change from baseline to Week 4, Week 8 and end of treatment (Week 12) in mean number of incontinence episodes per 24 hoursTimepoint: Baseline, Week 4, Week 8 and Week 12;Change from baseline to Week 4, Week 8 and end of treatment (Week 12) in mean number of micturitions per 24 hoursTimepoint: Baseline, Week 4, Week 8 and Week 12;Change from baseline to Week 4, Week 8 and end of treatment (Week 12) in mean number of urgency episodes per 24 hoursTimepoint: Baseline, Week 4, Week 8 and Week 12;Change from baseline to Week 4, Week 8 and end of treatment (Week 12) in mean number of urgency incontinence episodes per 24 hoursTimepoint: Baseline, Week 4, Week 8 and Week 12;Treatment emergent clinical & laboratory adverse events (TEAEs)Timepoint: All visits | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha MD
Hetero Drugs Limited
Outcome results
None listed