| CTRI Number |
CTRI/2009/091/000806 [Registered on: 30/10/2009] |
| Last Modified On: |
23/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical Trial in patients suffering from dysurea associated with benign prostatic hyperplasia. Clinical trial is to study efficacy, safety and tolerability of Silodosin Capsules 4 mg in comparison to Urief Capsules (reference product). |
Scientific Title of Study
Modification(s)
|
A comparative, single blind, parallel group, non-crossover, multi-centric trial of Silodosin Capsules 4 mg, with Urief Capsules, in-patients suffering from dysurea associated with benign prostatic hyperplasia. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| BIOS/CT/08/0701 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd, Advent 43 and 44,ABCD,Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Ajanta Pharma Ltd, Advent 43 and 44,ABCD,Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd, Advent 43 and 44,ABCD,Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Ajanta Pharma Ltd, Advent 43 and 44,ABCD,Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd, Advent 43 and 44,ABCD,Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Ajanta Pharma Ltd, Advent 43 and 44,ABCD,Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd, Advent 43 and 44,ABCD,Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Milind Kirloskar |
Dr. Kirloskar Clinic |
105, Amar Arcade,Sadhu Vasvani Road-422002
Nashik
MAHARASHTRA |
09823033684
mskirloskar@yahoo.com |
| Dr Sudhakar Gaikwad |
Gaikwad Nursing Home |
132, Samarth Nagar,,-431001
Aurangabad
MAHARASHTRA |
09822038892
sbg.2007@rediffmail.com |
| Dr K P Balashanmugam |
Trinity Multi Specialty Hospital |
Trinity Multi Specialty Hospital
Mylapore,-60000
Chennai
Chennai
TAMIL NADU |
04424465743
cr_chennai@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Jagruti Independent Ethics Committee Bandra Mumbai |
Approved |
| Jagruti Independent Ethics Committee Bandra Mumbai |
Approved |
| Lifeline Diabetes centre, 54/9-A, Lattice Bridge Road, Adyar, Chennai-20 |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N400||Benign prostatic hyperplasia without lower urinary tract symptoms, Dysurea associated with benign prostatic hyperplasia, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Silodosin Cpaules 4 mg |
Twice daily for 12 weeks |
| Comparator Agent |
Urief Capsules |
Twice daily for 12 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Day(s) |
| Gender |
Male |
| Details |
1. Male patients between 40 and 75 years of age
2. Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
3. Patient with signs and symptoms of Dysurea Associated with benign prostatic hyperplasia, diagnosed clinically.
|
|
| ExclusionCriteria |
| Details |
1. Patients <40 & > 75 years.
2. Patients with hypersensitivity to the drug.
3. Concomitant illness
4. Patients who have participated in a drug study in the past 3 months.
5. Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits
6. Use of enzyme-modifying drugs within 30 days prior to day 1 of this study.
7. HIV and Australian Antigen positive subjects.
8. Significant history or presence of glaucoma, cardiovascular or hematological disease.
9. Any condition which are likely to hinder the compliance with the protocol.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pharmacy-controlled Randomization |
Blinding/Masking
Modification(s)
|
Participant Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
A comparative evaluation of efficacy of Silodosin Capsules 4 mg, with Urief Capsules, in-patients suffering from dysurea associated with benign prostatic hyperplasia.
The efficacy parameters will primarily focus on improvement in the clinical signs & symptoms like Blood in the urine, Dribbling after voiding, Frequent urination, Hesitant, interrupted, or weak urine stream and Recurrent, sudden, urgent need to urinate.
|
Day 0, 1 week,2 week, 4 week,6 week, 8 week and 12 week. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| A comparative evaluation of safety & tolerability of Silodosin Capsules 4 mg, with Urief Capsules, in-patients suffering from dysurea associated with benign prostatic hyperplasia. |
Day 0, 1 week,
2 week, 4 week,6 week, 8 week and 12 week. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
07/12/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="5"
Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This syudy is a comparative, single blind, parallel group, non-crossover, multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Silodosin Capsules 4 mg Vs Urief Capsules, in 200, in patients suffering from dysurea associated with benign prostatic hyperplasia. Date of enrollment is 07 December 2009.
Out come will be measured at Day 0, 1 week, 2 week, 4 week, 6 week, 8 week and 12 week. in patients suffering from dysurea associated with benign prostatic hyperplasia. The efficacy parameters will primarily focus on improvement in the clinical signs & symptoms like Blood in the urine, Dribbling after voiding, Frequent urination, Hesitant, interrupted, or weak urine stream and Recurrent, sudden, urgent need to urinate. |