| CTRI Number |
CTRI/2021/09/036299 [Registered on: 07/09/2021] Trial Registered Prospectively |
| Last Modified On: |
20/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the safety and efficacy of fixed dose combination of Silodosin and Dutasteride in men with benign prostatic hyperplasia. |
|
Scientific Title of Study
|
A prospective, open-label, multi-center, single-arm, post
marketing study to evaluate the safety and efficacy of fixed dose
combination of Silodosin and Dutasteride in men with benign
prostatic hyperplasia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BRADPL/FDC/SDTC/06/19; Version 1.0; Date 10 June 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohtas K Sharma |
| Designation |
Consultant, Department of Urology |
| Affiliation |
Maharaja Agrasen Hospital |
| Address |
Maharaja Agrasen Hospital
West Punjabi Bagh
New Delhi
New Building
West Punjabi Bagh
New Delhi
West
DELHI
110026
India |
| Phone |
9810159346 |
| Fax |
|
| Email |
drrohtas.uro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Datta |
| Designation |
Managing Director |
| Affiliation |
Biosite Research Private Limited |
| Address |
Office No 81 - 84, 3rd Floor, Biosite Research Private Limited, 18th Main Road, RBI Layout, JP Nagar Phase 7, Bangalore
Office No 81 - 84, 3rd Floor, Biosite Research Private Limited, 18th Main Road, RBI Layout, JP Nagar Phase 7
Bangalore
KARNATAKA
560078
India |
| Phone |
9811788955 |
| Fax |
|
| Email |
aditi.datta@biositeindia.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Datta |
| Designation |
Managing Director |
| Affiliation |
Biosite Research Private Limited |
| Address |
Office No 81 - 84, 3rd Floor, Biosite Research Private Limited, 18th Main Road, RBI Layout, JP Nagar Phase 7, Bangalore
Office No 81 - 84, 3rd Floor, Biosite Research Private Limited, 18th Main Road, RBI Layout, JP Nagar Phase 7
Bangalore
KARNATAKA
560078
India |
| Phone |
9811788955 |
| Fax |
|
| Email |
aditi.datta@biositeindia.com |
|
|
Source of Monetary or Material Support
|
| Akums Drugs & Pharmaceuticals Limited |
|
|
Primary Sponsor
|
| Name |
Akums Drugs Pharmaceuticals Limited |
| Address |
304, Mohan Place, L.S.C., Block – C, Saraswati Vihar, Delhi – 1100348 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S N Sankhwar |
King Georges Medical University |
King Georges Medical University
Chowk Lucknow
Lucknow
UTTAR PRADESH |
9335901693
sankhwarsn_@yahoo.com |
| Dr Rohtas K Sharma |
Maharaja Agrasen Hospital |
Department of Urology
West Punjabi Bagh
New Delhi
West
DELHI |
9810159346
drrohtas.uro@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Health Point Ethics Committee Health Point Hopsital |
Approved |
| Institutional Ethics Committee Jasleen Hospital |
Approved |
| Institutional Ethics Committee, King Georges Medical University |
Submittted/Under Review |
| Institutional Ethics Committee, Maharaja Agrasen Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fixed dose combination of Silodosin 8 mg and Dutasteride 0.5 mg tablet in Capsule |
One capsule taken
orally daily with a meal for 84 days (12 weeks). |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
1. Male subjects of age 45 or above with current diagnosis of benign prostatic hyperplasia.
2. International prostate symptom score (IPSS) at presentation > 7.
3. Able to provide written informed consent and to comply with all study procedures. |
|
| ExclusionCriteria |
| Details |
1. History of clinically significant (as determined by the investigator) cardiac,
endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,
immunologic disease, or other major uncontrolled disease.
2. Patients with Prostate-Specific Antigen (PSA) level > 4.0ng/mL
3. History of allergy to any component of the IP.
4. Patients with a residual urinary volume of ≥250 ml.
5. Patients with severe renal impairment [Creatinine Clearance (CCr< 30 mL/min)].
6. Patients with severe hepatic impairment.
7. Subjects taking strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole,
clarithromycin, itraconazole, ritonavir).
8. Hypersensitivity to α1A-receptor blockers and 5 alpha-reductase inhibitors.
9. Presence of a condition or abnormality that in the opinion of the investigator would
compromise the safety of the patient or the quality of the data. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean change in International Prostate Symptom Score (IPSS).
2. Mean change in Peak Urine Flow Rate (Qmax). |
1. Day-7 to -1 (Visit 1), Day 28±2 ( visit 3), Day 56±2 (visit 4), Day 84±2 (Visit 5)
2. Day 01 (Visit 2) and Day 84±2 (Visit 5) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change from baseline in Quality of Life (QOL) due to urinary symptoms.
2. Percentage of treatment responders achieving decrease in IPSS score from baseline
of ≥25%. |
1. Day-7 to -1 (Visit 1), Day 28±2 ( visit 3), Day 56±2 (visit 4), Day 84±2 (Visit 5).
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/09/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
17/11/2021 |
|
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
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A prospective, open-label, multi-center, single-arm, post-marketing study to evaluate the safety and efficacy of fixed-dose combination of Silodosin and Dutasteride in men with benign prostatic hyperplasia.
PRIMARY OBJECTIVE
The primary objective of the study is to evaluate the safety of fixed dose combination of
Silodosin and Dutasteride in men with benign prostatic hyperplasia.
SECONDARY OBJECTIVE
The secondary objective of the study is to evaluate the efficacy of fixed dose combination of
Silodosin and Dutasteride in men with benign prostatic hyperplasia. |