A Clinical Study to Assess the Effectiveness and Side effects of Mirabegron PlusSolifenacin in Patients with Urinary Frequency and Urgency

Phase 3

Not yet recruiting

• Conditions: Other specified disorders of bladder,

• Registration Number: CTRI/2021/01/030395
• Lead Sponsor: Hetero Labs Limited

Brief Summary

This is a phase III, double-blind, active-control, parallel-group, randomized, prospective, multi-center, comparative efficacy and safety study. Primary objective is to evaluate the efficacy of Mirabegron and Solifenacin fixed

dose combination in patients with symptoms of overactive bladder (OAB) and secondary objective is to evaluate the tolerability and safety of Mirabegron and Solifenacin fixed dose combination in patients with symptoms

of OAB. Total study duration per patient is screening period up to 2 weeks (including wash-out period for patients who are on treatment for OAB based on the medication half-life up to 2 weeks) and 12 weeks of treatment period.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

• Adult male or female patients with age of 18 to 65 years 2.
• Patients who are treatment naïve or received prior anticholinergics medication 3.
• Patients with an average frequency of micturition of 8 or more times per 24-hour 4.
• Patients with an average episode of urgency with or without incontinence of one or more times per 24-hours period.

Exclusion Criteria

• Hypersensitive history to mirabegron, solifenacin, other antimuscarinic, other beta-adrenoreceptor (ß-AR) agonists 2.
• Currently have a clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal and/or other urological disorder 3.
• Patients with stress urinary incontinence as a predominant symptom 4.
• Patients with bladder outflow obstruction, urinary tract infection, urinary stones, and/or interstitial cystitis or chronic inflammation due to bladder pain syndrome or with a history of recurrent urinary tract infections 5.
• Patients with indwelling catheter or practicing intermittent self-catheterization 6.
• Patients with history of diabetic neuropathy 7.
• Currently participating in another investigational study or has participated in an investigational study within 90 days prior to randomization.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mean number of micturitions per 24 hours	Baseline and End of Week 12

Secondary Outcome Measures

Name	Time	Method
Change in mean number of micturitions per 24 hours	Baseline, Week 4 and Week 8
Change in mean number of incontinence episodes per 24 hours
Change in mean number of urgency episodes per 24 hours	Baseline, Week 4, Week 8 and Week 12
Change in OABSS score	Baseline, Week 4, Week 8 and
Treatment emergent clinical & laboratory adverse events	(TEAEs)

Trial Locations

Locations (8)

ACSR Government Medical College & Hospital; 🇮🇳 Nellore, ANDHRA PRADESH, India

Aman Hospital and Research Center; 🇮🇳 Vadodara, GUJARAT, India

Government Medical College & Government General Hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

IPGMER & SSKM Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

NRS Medical College & Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Osmania General Hospital; 🇮🇳 Hyderabad, TELANGANA, India

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

SMS Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

ACSR Government Medical College & Hospital

🇮🇳Nellore, ANDHRA PRADESH, India

Dr SK Noushad Ali

Principal investigator

9494828694

mddbnoal@gmail.com