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CTRI Number  CTRI/2022/12/048058 [Registered on: 13/12/2022] Trial Registered Prospectively
Last Modified On: 13/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   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 
Scientific Title of Study   A Multicenter, Randomized, Open-label, Parallel Group, Active Control, Phase III Study to Evaluate the Efficacy, Safety of Fixed Dose Combination of Silodosin 8 mg and Mirabegron 25/50 mg Tablets Versus Silodosin 8 mg Co-administered with Mirabegron 25/50 mg Tablets as Add-on Therapy in Adult Patients Diagnosed with Benign Prostatic Hyperplasia complicated by overactive bladder with Symptoms of Urge Urinary Incontinence, Urgency, and Frequency 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SIME/WBL/P3/2021, Version 1.0 Date:22 Sep 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Antaryami Maharana 
Designation  General manager Medical affairs and Pharmacovigilance  
Affiliation  Abiogenesis clinpharm private Limited  
Address  2nd Floor, Plot No 69, D No. 8-2-248_1_7_69, Nagarjuna Hills, Punjagutta

Hyderabad
TELANGANA
500082
India 
Phone  7702186021  
Fax    
Email  antaryami@abiogenesisclinpharm.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Antaryami Maharana 
Designation  General manager Medical affairs and Pharmacovigilance  
Affiliation  Abiogenesis clinpharm private Limited  
Address  2nd Floor, Plot No 69, D No. 8-2-248_1_7_69, Nagarjuna Hills, Punjagutta

Hyderabad
TELANGANA
500082
India 
Phone  7702186021  
Fax    
Email  antaryami@abiogenesisclinpharm.com  
 
Details of Contact Person
Public Query  
Name  Mr Prashant Dabral 
Designation  Head-Medico-Regulatory Affairs 
Affiliation  M/s. Windlas Biotech Limited 
Address  40/1, Mohabewala Industrial Area

Dehradun
UTTARANCHAL
248110
India 
Phone  0135-6608000  
Fax  0135-6608199  
Email  Prashant@windlasbiotech.com  
 
Source of Monetary or Material Support  
M/s. Windlas Biotech Limited, 40/1, Mohabewala Industrial Area, Dehradun, UTTARANCHAL-248110, India  
 
Primary Sponsor  
Name  M/s. Windlas Biotech Limited 
Address  40/1, Mohabewala Industrial Area, Dehradun – 248 110, Uttarakhand, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dilip Namdev Kadam  Care Multispeciality Hospital  Medicine OPD department, Room no:05, 1ST Floor,Kotle Areade, Pune-Nagar Road, Wagholi, Pune-412207
Pune
MAHARASHTRA 		 7066115411

dr.dilipkadam12@gmail.com 
Dr Ashok Kumar Gupta  Maharaja Agrasen Hospital  Department of urology,Room No 4,Ground floor,Maharaja Agrasen Hospital, West Punjabi Bagh, New Delhi-110026
West
DELHI 		 9810046353

akg.urogyn@gmail.com 
Dr Tapas Kumar Majhi  Nil Ratan Sircar Medical College and Hospital   Department of urology, Ground Floor, 138, AJC Bose Road , Kolkata 700014
Kolkata
WEST BENGAL 		 9830160266

drtapasuro@gmail.com 
Dr Vijay kumar Barge   Rajarshee Chhstrspati Shahu Maharaj Government Medical College & Chhatrapati Pramila Raje Hospital  Medicine Department,3rd Floor,Vedganga Building, Dasara Chowk, Bhausingji road, Town Hall, Kolhapur-416012, Maharashtra, India
Kolhapur
MAHARASHTRA 		 9011066766

drvijaybarge12@gmail.com 
Dr Prasad PVGS  Renova Neelima Hospitals  1st floor, A Block,Opp. Voltas company, Sanathnagar, Hyderabad-500018, Telangana
Hyderabad
TELANGANA 		 9985949478

prasadmbbs2k@gmail.com 
Dr Anil Kumar Sanwal  Sanwal Hospital  OPD,Room no:01, Ground floor, Kanpur Road, Near University, Jhansi (UP) – 284128
Jhansi
UTTAR PRADESH 		 9415057207

aksanwal8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Care Multispeciality Hospital Institutional Ethics committee   Approved 
Ethics Committee-NRS Medical College  Submittted/Under Review 
Institutional Ethics Committee- Neelima Hospitals  Submittted/Under Review 
Maharaj Agrasen Hospital, Institutional Ethics committee  Submittted/Under Review 
Nirmal Hospital Institutional Ethics committee  Approved 
RCSMGMCIEC2 RCSMGMC and CPR Hospital  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N33||Bladder disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fixed Dose Combination of Silodosin 8 mg and Mirabegron 25/50 mg Tablets  Fixed Dose Combination of Silodosin 8 mg and Mirabegron 25/50 mg Tablets as add on therapy. Daily one tablet for 12 weeks 
Comparator Agent  Silodosin 8 mg Co-administered with Mirabegron 25/50 mg Tablets  Silodosin 8 mg Co-administered with Mirabegron 25/50 mg Tablets as add on therapy Daily 1 tablet of Silodosin and 1 tablet of mirabegron 25/50 for 12 weeks  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  1. 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. 
 
ExclusionCriteria 
Details  1. 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.
9. 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 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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 		 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  
Outcome  TimePoints 
Safety Assessments
ï‚· Adverse events (AEs) during the study
Proportion of subjects with adverse events and serious adverse
events during treatment period.
Adverse events including medically significant laboratory changesincidence,
severity, causality and outcome will be collected from the
signing of informed consent form until discontinuation of study treatment
due to disease progression, intolerability, withdrawal of consent, death or
treatment completion 		 Baseline, Week 4, Week 8 and week 12 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="240" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/12/2022 
Date of Study Completion (India) 06/10/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.
 
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