Study to understand the Efficacy, Safety of Silodosin 8 mg and Mirabegron 25/50 mg Tablets compared to Silodosin 8 mg Co-administered with Mirabegron 25/50 mg Tablets in Benign Prostatic Hyperplasia

Phase 3

Completed

• Conditions: Bladder disorders in diseases classified elsewhere,

• Registration Number: CTRI/2022/12/048058
• Lead Sponsor: M/s. Windlas Biotech Limited

Brief Summary

This will be an open label, prospective, multi-center, four arms, active control study to evaluate safety and efficacy of Fixed Dose Combination (FDC) of Silodosin 8 mg and Mirabegron 25/50 mg Tablets and compare with Silodosin 8 mg tablets co-administered with Mirabegron 25/50 mg tablets in subjects with Benign Prostatic Hyperplasia complicated by overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Initially, subjects who require treatment with Silodosin and Mirabegron will be screened as per predefined eligibility criteria for the study. Eligible subjects will be enrolled in a 1:1:1:1 ratio into one of the four Groups to receive treatment with FDC of Silodosin 8 mg and Mirabegron 25 mg tablets or FDC of Silodosin 8 mg and Mirabegron 50 mg tablets of Windlas Biotech Limited or Silodosin 8 mg tablets coadministered with Mirabegron 25 mg tablets or Silodosin 8 mg tablets coadministered with Mirabegron 50 mg tablets for 12 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-15
• Study Completion: 2023-06-10
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 240

Inclusion Criteria

• Male subjects aged 45 to 65 years (both inclusive) with confirmed diagnosis of Benign Prostatic Hyperplasia complicated by overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency (including micturitions greater than or equal to8 per day and urinary urgency episodes greater than or equal to per day).2.
• Subjects willing to give voluntary their written informed consent to participate in the study before being screened for the study.3. Able to adhere to study visit schedule and other protocol requirements.

Exclusion Criteria

• Subject having a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction 2.
• Subject having Urinary retention requiring catheterization 3.
• Subject having symptomatic, untreated urinary tract infection not resolved prior to starting of investigational products 4.
• Subject taking Botulinum toxin injection for Urgency Urinary Incontinence UUI in the last year 5.
• Current therapy with peripheral or sacral neuromodulation 6.
• Neurologic conditions that may affect urinary function like stroke,multiple sclerosis, spinal cord injury, Parkinsons disease 7.
• Subjects with significant cardiac disorder e.g. cardiac valve disease requiring a specific treatment, pericardial constriction, Life threatening arrhythmia, uncontrolled hypertension, Acute myocardial infarction, permanent atrial fibrillation 8.
• Subjects with severe renal insufficiency or ongoing or planned dialysis.
• Subjects with documented severe hepatic impairment with or without cirrhosis according to National Cancer Institute organ dysfunction working group criteria, defined as total bilirubin greater than 3 times ULN accompanied by AST greater than ULN assessed at screening and or Child Pugh Class C 10.
• Serum AST and or ALT greater than 3 times ULN assessed at screening 11.
• Men who are unwilling to use contraception while receiving investigational product 12.
• Known or suspected hypersensitivity to investigational products or any other component of the formulation 13.
• Failure to control systemic fungal, bacterial or viral infection 14.
• Known human immunodeficiency virus HIV or hepatitis B or C classes of active viral infection 15.
• Subjects with suspected signs and symptoms of COVID19 or confirmed novel coronavirus infection COVID19 or with a recent history of travel or contact with any COVID19 positive subject or isolation or quarantine in the last 14 days 16.
• Have a history of neurological or psychiatric disorders, including epilepsy or dementia 17.
• According to the investigators judgment, there are concomitant diseases with a serious safety hazard or affect the subjects participation in the study in subjects 18.
• Using other experimental drugs or participating in other clinical trials in the prior one month 19.
• Concomitant life-threatening disease with a life expectancy less than 12 months 20.
• Any factor or condition likely to affect protocol compliance of the subject as judged by the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint:	Primary endpoint: | Change in Total Overactive Bladder Symptom Score (OABSS) from baseline to week 12 | Secondary endpoint: | Number of Micturitions Per 24 Hours at week 4, week 8 and week 12 and compare to baseline (Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI)). | Number of micturition Urgency Episodes per 24 Hours at week 4 and week 8 and week 12 | Number of UUI Episodes Per 24 Hours at week 4 and week 8 and week 12 | Number of Nighttime Micturitions Per 24 Hours at week 4 and week 8 and week 12
Change in Total Overactive Bladder Symptom Score (OABSS) from baseline to week 12	Primary endpoint: | Change in Total Overactive Bladder Symptom Score (OABSS) from baseline to week 12 | Secondary endpoint: | Number of Micturitions Per 24 Hours at week 4, week 8 and week 12 and compare to baseline (Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI)). | Number of micturition Urgency Episodes per 24 Hours at week 4 and week 8 and week 12 | Number of UUI Episodes Per 24 Hours at week 4 and week 8 and week 12 | Number of Nighttime Micturitions Per 24 Hours at week 4 and week 8 and week 12
Secondary endpoint:	Primary endpoint: | Change in Total Overactive Bladder Symptom Score (OABSS) from baseline to week 12 | Secondary endpoint: | Number of Micturitions Per 24 Hours at week 4, week 8 and week 12 and compare to baseline (Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI)). | Number of micturition Urgency Episodes per 24 Hours at week 4 and week 8 and week 12 | Number of UUI Episodes Per 24 Hours at week 4 and week 8 and week 12 | Number of Nighttime Micturitions Per 24 Hours at week 4 and week 8 and week 12
Number of Micturitions Per 24 Hours at week 4, week 8 and week 12 and compare to baseline (Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI)).	Primary endpoint: | Change in Total Overactive Bladder Symptom Score (OABSS) from baseline to week 12 | Secondary endpoint: | Number of Micturitions Per 24 Hours at week 4, week 8 and week 12 and compare to baseline (Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI)). | Number of micturition Urgency Episodes per 24 Hours at week 4 and week 8 and week 12 | Number of UUI Episodes Per 24 Hours at week 4 and week 8 and week 12 | Number of Nighttime Micturitions Per 24 Hours at week 4 and week 8 and week 12
Number of micturition Urgency Episodes per 24 Hours at week 4 and week 8 and week 12	Primary endpoint: | Change in Total Overactive Bladder Symptom Score (OABSS) from baseline to week 12 | Secondary endpoint: | Number of Micturitions Per 24 Hours at week 4, week 8 and week 12 and compare to baseline (Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI)). | Number of micturition Urgency Episodes per 24 Hours at week 4 and week 8 and week 12 | Number of UUI Episodes Per 24 Hours at week 4 and week 8 and week 12 | Number of Nighttime Micturitions Per 24 Hours at week 4 and week 8 and week 12
Number of UUI Episodes Per 24 Hours at week 4 and week 8 and week 12	Primary endpoint: | Change in Total Overactive Bladder Symptom Score (OABSS) from baseline to week 12 | Secondary endpoint: | Number of Micturitions Per 24 Hours at week 4, week 8 and week 12 and compare to baseline (Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI)). | Number of micturition Urgency Episodes per 24 Hours at week 4 and week 8 and week 12 | Number of UUI Episodes Per 24 Hours at week 4 and week 8 and week 12 | Number of Nighttime Micturitions Per 24 Hours at week 4 and week 8 and week 12
Number of Nighttime Micturitions Per 24 Hours at week 4 and week 8 and week 12	Primary endpoint: | Change in Total Overactive Bladder Symptom Score (OABSS) from baseline to week 12 | Secondary endpoint: | Number of Micturitions Per 24 Hours at week 4, week 8 and week 12 and compare to baseline (Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI)). | Number of micturition Urgency Episodes per 24 Hours at week 4 and week 8 and week 12 | Number of UUI Episodes Per 24 Hours at week 4 and week 8 and week 12 | Number of Nighttime Micturitions Per 24 Hours at week 4 and week 8 and week 12

Secondary Outcome Measures

Name	Time	Method
Safety Assessments	ï‚· Adverse events (AEs) during the study

Trial Locations

Locations (6)

Care Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Maharaja Agrasen Hospital; 🇮🇳 West, DELHI, India

Nil Ratan Sircar Medical College and Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Rajarshee Chhstrspati Shahu Maharaj Government Medical College & Chhatrapati Pramila Raje Hospital; 🇮🇳 Kolhapur, MAHARASHTRA, India

Renova Neelima Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

Sanwal Hospital; 🇮🇳 Jhansi, UTTAR PRADESH, India

Care Multispeciality Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Dilip Namdev Kadam

Principal investigator

7066115411

dr.dilipkadam12@gmail.com