| CTRI Number |
CTRI/2010/091/001119 [Registered on: 21/07/2010] |
| Last Modified On: |
14/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study effectiveness and safety of Udenafil tablets in patients suffering from erectile dysfunction |
Scientific Title of Study
Modification(s)
|
A randomized, double blind, placebo controlled, multicentric study to assess the efficacy and safety of Udenafil tablets in patients suffering from erectile dysfunction |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 09-23 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
|
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Road
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
|
| Affiliation |
Cadila Healthcare Ltd. |
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
|
| Affiliation |
|
| Address |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads
Ahmadabad
GUJARAT
380015
India |
| Phone |
07926868926 |
| Fax |
07926862362 |
| Email |
r.mittal@zyduscadila.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Cadila Healthcare Ltd |
| Address |
Zydus Tower Satellite Cross Roads
Ahmadabad GUJARAT 380015 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 = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Mukul Choksi |
Angat Clinic, Surat |
Angat, Shankheshwar complex,Majuragate-395001
Surat
GUJARAT |
mukulchoksi@gmail.com |
| Dr. Kapil Kochhar |
Centre for Male Infertility & Men's Health Clinic, Indore |
Centre for Male Infertility & Men's Health Clinic,,110,111, Sterling Arcade, 15/3 Race Course Road,-
Indore
MADHYA PRADESH |
drkapilkochhar@gmail.com |
| Dr. Tushar Jagawat |
Manasthali, Jaipur |
Manasthali, 33/147, Varun Path,Mansarovar-302020
Jaipur
RAJASTHAN |
tusharjagawat@yahoo.com |
| Dr Ajit Saxena |
Menz Health Clinic, Noida |
Menz Health Clinic,X-9, Sector 12-Noida
Gautam Buddha Nagar
UTTAR PRADESH |
0101202552178
0101202552178
ajitsaxena@hotmail.com |
| Dr. Mrugesh D. Vaishnav |
Samvedana Psychiatric & Sex Therapy Clinic, Ahmedabad |
Samvedana Psychiatric & Sex Therapy Clinic,,Shri Mahalaxmi Towers, Karnavati Hospital Building, Ellisbridge-380006
Ahmadabad
GUJARAT |
drmrugesh@rediffmail.com |
| Dr. T.S. Sathyanarayana Rao |
Suman Vinayaka Nursing Home, Mandya |
Suman Vinayaka Nursing Home,100 Ft. Road-571401
Mandya
KARNATAKA |
tssrao19@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee - Aditya (Dr Ajit Saxena) |
Approved |
| Independent Ethics Committee - Aditya (Dr. Kapil Kochhar) |
Approved |
| Independent Ethics Committee - Aditya (Dr. Mrugesh D. Vaishnav) |
Approved |
| Independent Ethics Committee - Aditya (Dr. Mukul Choksi) |
Approved |
| Independent Ethics Committee - Aditya (Dr. T.S. Sathyanarayana Rao) |
Approved |
| Independent Ethics Committee - Aditya (Dr. Tushar Jagawat ) |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Erectile dysfunction, (1) ICD-10 Condition: N529||Male erectile dysfunction, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Matching Placebo tablets |
30 minutes to 1 hour before anticipated sexual intercourse, for 8 weeks |
| Intervention |
Udenafil 100 mg tablets |
30 minutes to 1 hour before anticipated sexual intercourse, for 8 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. Male patients of 18 to 60 years of age
2. Stable, monogamous heterosexual relationship
3. Established diagnosis of erectile dysfunction (ED)
4. Informed consent of the patient |
|
| ExclusionCriteria |
| Details |
1. Total erectile failure or any other sexual disorder
2. Hypogonadism or anatomical deformity of the penis such as severe penile fibrosis or Peyronie?s disease or penile trauma
3. History of major psychiatric disorder
4. History of significant pathological cardiovascular conditions such as: congestive heart failure, life-threatening arrhythmia or ischemic heart disease
5. History of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery
6. Patients with hypotension or uncontrolled hypertension, uncontrolled diabetes, hepatic impairment, renal impairment or hematological disorders
7. History of retinitis pigmentosa, proliferative diabetic retinopathy or non-arteritic anterior ischemic optic neuropathy (NAION)
8. History of disorders that may cause priapism
9. Any concomitant treatment which is not permissible
10. Known hypersensitivity to PDE 5 inhibitors
11. Any other serious concurrent illness or malignancy
12. Continuing history of alcohol and / or drug abuse
13. Recent participation in another clinical trial |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The change in the Erectile function domain of IIEF questionnaire |
Baseline, 4 & 8 Weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
(1) The change in the total score of IIEF questionnaire
(2) Patient?s global impression of change
(3) Overall assessment of efficacy
|
Baseline, 4 & 8 Weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
28/07/2010 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
“none yet†|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized, double blind, placebo controlled, multicentric study comparing the safety and efficacy of Udenafil 100 mg tablets and matching placebo given 30 minutes to 1 hour before anticipated sexual intercourse each for 8 weeks; in 120 patients with erectile dysfunction that will be conducted in five centers in India. The primary outcome measures will be the change in the Erectile function domain of IIEF questionnaire.. |