| CTRI Number |
CTRI/2021/12/038596 [Registered on: 13/12/2021] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| 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 Trial to Evaluate the Efficacy, Safety of Fesoterodine Fumarate Extended Release Tablets 4 mg / 8 mg Versus Solifenacin Succinate Tablets 5 mg/10 mg in Adult Patients Diagnosed with Overactive Bladder with Symptoms of Urge Urinary Incontinence, Urgency, and Frequency. |
|
Scientific Title of Study
|
A Prospective, Multicenter, Randomized, Double-blind, Parallel Group, Active Control, Comparative Phase III Study to Evaluate the Efficacy, Safety of Fesoterodine Fumarate Extended Release Tablets 4 mg / 8 mg Versus Solifenacin Succinate Tablets 5 mg/10 mg in Adult Patients Diagnosed with Overactive Bladder with Symptoms of Urge Urinary Incontinence, Urgency, and Frequency. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| FESO/MSN/P3/2020; Version 3.0; Date 27.09.2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditi Datta |
| Designation |
Managing Director |
| Affiliation |
Biosite Research Private Limited |
| Address |
Office No 81, 82, 83 & 84 3rd Floor Chandru Complex, 18th Main RBI, Layout JP Nagar Phase 7, Bangalore
Bangalore
KARNATAKA
560078
India |
| Phone |
9811788955 |
| Fax |
|
| Email |
aditi.datta@biositeindia.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Datta |
| Designation |
Managing Director |
| Affiliation |
Biosite Research Private Limited |
| Address |
Office No 81, 82, 83 & 84 3rd Floor Chandru Complex, 18th Main RBI, Layout JP Nagar Phase 7, Bangalore
Bangalore
KARNATAKA
560078
India |
| Phone |
9811788955 |
| Fax |
|
| Email |
aditi.datta@biositeindia.com |
|
Details of Contact Person
Public Query
|
| Name |
K Ravinder Reddy |
| Designation |
GM Indian Regulatory Affairs |
| Affiliation |
MSN Laboratories Private Limited |
| Address |
Plot No C-24, MSN House, Industrial Estate, Sanath Nagar, Hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
04030438712 |
| Fax |
04030438667 |
| Email |
krreddy@msnlabs.com |
|
|
Source of Monetary or Material Support
|
| MSN Laboratories Private Limited, MSN House: Plot No: C-24, Industrial Estate, Sanathnagar, Hyderabad -500 018, Telangana, India. |
|
|
Primary Sponsor
|
| Name |
MSN Laboratories Private Limited |
| Address |
MSN House, Plot No C-24, Industrial Estate, Sanathnagar, Hyderabad -500018, Telangana, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Patankar Suresh Balakrishna |
ACE Hospital and Research Centre |
Department of Urology, 32/2A, Erandawane, Gulawani, Maharaj road, Pune 411004
Pune
MAHARASHTRA |
9881256992
sureshpatankarace@gmail.com |
| Dr A Gopal Rao |
Government of Medical College and Government General Hospital |
Department of Urology, Srikakulam 532001
Srikakulam
ANDHRA PRADESH |
8942279033
drgopalraoa@gmail.com |
| Dr Prakash HS |
K R Hospital |
Mysore Medical College and
Research institute, lrwin, Road, Irwin, Road,
Mysuru-570001, Karnataka,
lndia
Mysuru -570001, Karnataka,
lndia
Mysore
KARNATAKA |
9880840543
drhsprakash@gmail.com |
| Dr Ranjan Kumar Dey |
Life Line Diagnostic Centre CUM Nursing Home |
4A, Wood Street, Kolkata-
700016. (West Bengal)
Kolkata
WEST BENGAL |
9831046873
ranjankdey@rediffmail.com |
| Dr Prasad V Magdum |
Magdum Endo Surgery Institute |
Opp Shastri Nagar Ground, Pratibha Nagar, Kolhapur
Kolhapur
MAHARASHTRA |
9890649997
dr.prasad.magdum@gmail.com |
| Dr Ashok Kumar Gupta |
Maharaja Agrasen Hospital |
Near Metro Station Jain Muni
Guru Ramakrishnan Marg Block
C, Shivaji Park, West Punjabi
Bagh, Delhi, 110026
West
DELHI |
011-40777744
akg.urogyn@gmail.com |
| Dr Narashimhaswamy P |
Mandya Institute of Medical Sciences |
MC Road,Nehrunagar, Mandya
Mandya
KARNATAKA |
9980867647
nswamy87@gmail.com |
| Dr Tapan Kumar Mandal |
NRS Medical College & Hospital |
Department of
Urology, NRS Medical College
& Hospital, 138 AJC Bose
Road, kolkata-700014, West
Bengal, India Kolkata WEST
BENGAL
Kolkata
WEST BENGAL |
9830367795
drtapanmondal@yahoo.in |
| Dr Rajeev Sood |
PGIMER, DR. RAM MANOHAR LOHIA HOSPITAL |
Baba Khadakh
Singh Marg New Delhi New
Delhi Central Delhi Delhi -
110001 India
Central
DELHI |
9810005182
drsoodr@gmail.com |
| Dr Manmeet Singh |
Vidhya Hospital & Trauma Centre |
Department of Urology, Harikansh Garhi,
Raebareli Road, Mohanlalganj, Lucknow 226301
Lucknow
UTTAR PRADESH |
9792957585
dr.manudocuro@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr RML Hospital |
Approved |
| AMAI Trust ACE Hospital IEC |
Approved |
| Ethics Committee, N.R.S. Medical College NRS Medical College and Hospital |
Approved |
| IEC Life Line Diagnostic Centre CUM Nursing Home |
Approved |
| Institution Ethics Committee, MIMS, Mandya |
Submittted/Under Review |
| Institutional Ethics Committee Mysore Medical College |
Approved |
| Institutional Ethics Committee, Government of Medical College and Government General Hospital |
Approved |
| Maharaja Agrasen Hospital Institutional Ethics Committee (MAH IEC) |
Approved |
| Om Sai Onco Institutional Ethics Committee |
Approved |
| Vidhya Hospital & Trauma Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N329||Bladder disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fesoterodine Fumarate Extended Release Tablets |
Fesoterodine Fumarate Extended Release 4mg/8mg Tablets.
Dose: once daily with or after food, for at least 4 weeks and Maximum 12 week.
Route of administration: Oral |
| Comparator Agent |
Solifenacin Succinate Tablets |
Solifenacin Succinate 5 mg/10 mg Tablets.
Dose:Once daily with or after food, for at least 4 weeks and Maximum 12 week.
Route of Administration: Oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects aged 18 to 65 years (both inclusive) with a confirmed diagnosis of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency (including micturitions greater than equals to 8 per day and urinary urgency episodes greater than equals to 1 per day)
2. Subjects willing to give voluntarily their written informed consent to participate in the study before being screened for the study.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. All women of childbearing potential must use adequate contraception throughout the study and four weeks after completion of the study or be celibate or their partner must have had a vasectomy. The screening urine pregnancy tests should be negative (if the urine pregnancy test is positive, a serum pregnancy test should be performed, and the result should be negative). Women who have been surgically sterilized or are at least two years menopausal may be enrolled and do not need to use birth control. |
|
| ExclusionCriteria |
| Details |
1. Subject having a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse
2. Contraindications to fesoterodine (e.g. bladder outlet obstruction, narrow angle glaucoma, myasthenia gravis, severe hepatic or renal impairment)
3. Subject having Urinary retention requiring catheterization.
4. Subject having symptomatic, untreated urinary tract infection not resolved prior to starting fesoterodine.
5. Subject taking Botulinum toxin injection for Urgency Urinary Incontinence (UUI) in the last year.
6. Current therapy with peripheral or sacral neuromodulation.
7. Neurologic conditions that may affect urinary function (stroke, multiple sclerosis, spinal cord injury, Parkinsons disease).
8. Subjects with significant cardiac disorder (e g cardiac valve disease requiring specific treatment, pericardial constriction, Life threatening arrhythmia, uncontrolled hypertension, Acute myocardial infarction, permanent atrial fibrillation).
9. Subjects with severe renal insufficiency or ongoing or planned dialysis.
10. 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 of ULN accompanied by AST greater than of ULN (assessed by central laboratory at screening) and or Child-Pugh Class C.
11. Serum AST and or ALT greater than 3 times of ULN (assessed by centrallaboratory at screening). 12. Women of childbearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study.
13. Men who are unwilling to use contraception while receiving Fesoterodine.
14. Prior treatment with Fesoterodine.
15. Known or suspected hypersensitivity to Fesoterodine or any other component of the formulation.
16. Failure to control systemic fungal, bacterial or viral infection.
17. Known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection.
18. Subjects with suspected signs and symptoms of COVID-19 or confirmed novel coronavirus infection COVID-19 or with a recent history of travel or contact with any COVID-19 positive subject or isolation or quarantine in last 14 days.
19. Have a history of neurological or psychiatric disorders, including epilepsy or dementia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of Micturitions Per 24 Hours |
week 4, week 8 and week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of Urgency Episodes per 24 Hours |
week 4 and week 8 and week 12 |
| Number of UUI Episodes Per 24 Hours |
week 4 and week 8 and week 12 |
| Number of Number of Nighttime Micturitions Per 24 Hours |
week 4 and week 8 and
week 12 |
| Safety Assessments |
week 4, week 8 and week 12 |
|
|
Target Sample Size
|
Total Sample Size="216"
Sample Size from India="216"
Final Enrollment numbers achieved (Total)= "207"
Final Enrollment numbers achieved (India)="216" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/12/2021 |
| Date of Study Completion (India) |
20/06/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This will be a double blind, prospective, multi-centre, two arms, active control study to evaluate safety and efficacy of Fesoterodine fumarate extended release tablets 4mg/8 mg and compare with Solifenacin succinate tablets 5 mg/10 mg in subjects with overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Initially, subjects who require treatment with Fesoterodine and Solifenacin will be screened as per predefined eligibility criteria for the study. Eligible 216 subjects (108 per arm) will be enrolled to receive treatment with either Fesoterodine fumarate extended-release tablets of M/s.MSN laboratories private limited or Solifenacin tablets for 12 weeks. Each subject randomized to test group will receive Fesoterodine fumarate Extended Release Tablets orally once daily and subjects randomized to reference group will receive
Solifenacin succinate tablets once daily.
At 4 weeks or 8 weeks, subjects will have dose titration based on investigator discretion for the Fesoterodine dose from 4 mg to 8 mg based on treatment response and tolerability as per investigator discretion. Similarly, subjects on Solifenacin succinate tablets will have dose titration from 5 mg to 10 mg at week 4 or week 8 as per investigator discretion. Subjects will initiate with a dose of 4mg till the 4th week. If the subject is responding well to 4mg, they will continue on 4mg till 8th week (total 8 weeks) or till EOS (total 12 weeks).
Based on the treatment response and tolerability, the dose may be escalated to 8mg during the week 4 visit. The subject will continue on 8mg till EOS (total 8 weeks). There will be no de-escalation of dose. If the drug is not tolerated, the subject will be excluded from the study. Similarly, the dose may be escalated from 4mg to 8mg on week 8 visit. The subject will continue on 8mg till EOS (total 4 weeks). The same method will be followed for the comparator group for escalation from 5mg to 10mg on Week 4 or Week 8 visit.
Efficacy analysis will be conducted in per-protocol subjects and the safety analysis will be conducted in all randomized subjects. All subjects in this study will be assigned in ratio of 1:1 respectively to the test and comparator product.
|