A clinical Study to Evaluate the Efficacy and Safety of Mirabegron in Indian Adult Patients with Symptoms of Overactive Bladder

Phase 3

Active, not recruiting

• Conditions: Other specified disorders of bladder,

• Registration Number: CTRI/2016/10/007409
• Lead Sponsor: Hetero Labs Limited

Brief Summary

This is a phase III, double blind, double dummy, active control, parallel group, randomized, prospective, multicenter, efficacy and safety study. The randomization would be in 1:1:1 ratio among the study treatments. Adult male and female (18-55 years) patients with symptoms of Overactive Bladder (OAB), who will meet all the inclusion criteria and none of the exclusion criteria will be enrolled.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-11
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

• 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

• 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).
• 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
Change from baseline to end of treatment (Week 12) in mean number of micturitions per 24 hours	Baseline and Week 12

Secondary Outcome Measures

Name	Time	Method
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 Questionnaire	Baseline, Week 4, Week 8 and Week 12
Treatment emergent clinical & laboratory adverse events (TEAEs)	All visits
Change from baseline to Week 4, Week 8 and end of treatment (Week 12) in mean number of micturitions per 24 hours	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 hours	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 hours	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 hours	Baseline, Week 4, Week 8 and Week 12
Change from baseline to end of treatment (Week 12) in mean volume voided per micturition	Baseline and Week 12

Trial Locations

Locations (4)

Noble Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Paras Hospital; 🇮🇳 Gurgaon, HARYANA, India

Post Graduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, CHANDIGARH, India

RIMS Govt. General Hospital,; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Noble Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Abhirudhra Mulay MBBS MS DNB Urology

Principal investigator

02066285000

drabhirudhramulay@gmail.com