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CTRI Number  CTRI/2016/10/007409 [Registered on: 26/10/2016] Trial Registered Prospectively
Last Modified On: 18/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical Study to Evaluate the Efficacy and Safety of Mirabegron in Indian Adult Patients with Symptoms of Overactive Bladder 
Scientific Title of Study   A Phase III, Multi-Center, Double Blind, Comparative, Active-Controlled, Parallel Group, Randomized Study to Evaluate the Efficacy and Safety of Mirabegron in Indian Adult Patients with Symptoms of Overactive Bladder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HCR/III/MIRABOB/01/2015 Version 1.2 dated 26-Feb-2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Sreenivasa Chary S 
Designation  Assistant General Manager 
Affiliation  Hetero Drugs Limited 
Address  “Hetero Corporate”,7-2-A2, Industrial Estates, Sanath Nagar Hyderabad ANDHRA PRADESH 500018 India

Hyderabad
ANDHRA PRADESH
500018
India 
Phone  91-40-23704923  
Fax  91-40-23801902  
Email  sreenivasa.chary@heterodrugs.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubhadeep Sinha MD 
Designation  Vice-President and Head 
Affiliation  Hetero Drugs Limited 
Address  “Hetero Corporate”,7-2-A2, Industrial Estates, Sanath Nagar Hyderabad ANDHRA PRADESH 500018 India

Hyderabad
ANDHRA PRADESH
500018
India 
Phone  91-40-23704923  
Fax  91-40-23801902  
Email  sd.sinha@heterodrugs.com  
 
Source of Monetary or Material Support  
Hetero Labs Limited, “Hetero Corporate”, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad- 500018, India Tel: 91-40-23704923/24/25; Fax: 91-40-23704926 
 
Primary Sponsor  
Name  Hetero Labs Limited 
Address  Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad- 500018, India Tel: 91-40-23704923/24/25; Fax: 91-40-23704926 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhirudhra Mulay MBBS MS DNB Urology  Noble Hospital  153,Magarpatta City road,Hadapsar Pune-411013
Pune
MAHARASHTRA 		 02066285000

drabhirudhramulay@gmail.com 
Dr Anurag Khaitan MBBS MS MCH Urology  Paras Hospital  C-1,Sushant Lok-1,Sector-43,Gurgaon,Haryana- 122002
Gurgaon
HARYANA 		 0124-4585666

Info@parashospitals.com 
Dr Ravi Mohan MSMch Urology  Post Graduate Institute of Medical Education and Research  Dept. Of Urology,Sector-12,Chandigarh,-160012
Chandigarh
CHANDIGARH 		 0172-2747585-91

ravismi2003@yahoo.com 
Dr D Prasada Rao MSGeneral Surgery  RIMS Govt. General Hospital,   Dept. Of Surgery, Srikakulam-532001 AP,India
Srikakulam
ANDHRA PRADESH 		 91-8942-279033

rimsresearch@gamil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethics Committee Noble Hospital ,153,Magarpatta City road,Hadapsar Pune-411013  Submittted/Under Review 
Institutional Ethics Committee Of Post Graduate Institute of Medical education and research ,Sector-12,Chandigarh  Submittted/Under Review 
Institutional Ethics Committee, RIMS &RIMS Govt. General Hospital, Srikakulam-532001 AP,India  Approved 
Paras Hospital Ethics Committee, Paras Hospital,C-1,Sushant Lok-1,Sector-43,Gurgaon,Haryana- 122002  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Adult Patients with Symptoms of Overactive Bladder, (1) ICD-10 Condition: N328||Other specified disorders of bladder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 Hetero orally once daily for 12 weeks 
Comparator Agent  Tolterodine 4 mg  A. Tolterodine 4 mg extended release Capsule manufactured by Hetero orally, once daily for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 <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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Change from baseline to end of treatment (Week 12) in mean number of micturitions per 24 hours  Baseline and Week 12 
 
Secondary Outcome  
Outcome  TimePoints 
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 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 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 end of treatment (Week 12) in mean volume voided per micturition  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 Questionnaire  Baseline, Week 4, Week 8 and Week 12 
Treatment emergent clinical & laboratory adverse events (TEAEs)  All visits 
 
Target Sample Size   Total Sample Size="312"
Sample Size from India="312" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/11/2016 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

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. 
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