| CTRI Number |
CTRI/2010/091/001055 [Registered on: 29/06/2010] |
| Last Modified On: |
13/11/2018 |
| 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 to study effectiveness and safety of Revaprazan tablets in comparison with Omeprazole capsules in patients suffering from Peptic Ulcer or Acute Gastritis |
Scientific Title of Study
Modification(s)
|
A randomized, open label, comparative, multicentric study to assess the efficacy and safety of Revaprazan tablets in comparison with Omeprazole capsules in patients suffering from Peptic Ulcer or Acute Gastritis |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 09-15 |
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 Roads
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 |
Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads, Ahmedabad. 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. Manish Bhatnagar |
Dr. Manish Bhatnagar's Clinic |
201, Kamdhenu Complex,Toran Dining Hall Lane, Ashram Road-380009
Ahmadabad
GUJARAT |
079-7542966
man_bhatnagar@yahoo.com |
| Dr. Sandeep Nijhawan |
Dr. Nijhawan Clinic, Jaipur |
Panchasheel Enclave, Near Clark Hotel,Gokul bhai Bhatt Marg, Durgapura-302018
Jaipur
RAJASTHAN |
dr_nijhawan@yahoo.com |
| Dr. Atul Shende |
GUT-N-HEPA CARE, Indore |
201, Manav Trade Centre,Near Gokuldas Hospital, South Tukoganj-452001
Indore
MADHYA PRADESH |
dratulshende@yahoo.co.in |
| Dr. Sunil Gupta |
K2 Clinic, Jaipur |
K2 Clinic,14/201, Malviya Nagar-302017
Jaipur
RAJASTHAN |
|
| Dr. Sunil Dadhich |
Kala Endoscopy & Liver Clinic, Jodhpur |
Kala Endoscopy & Liver Clinic,Subhash Nagar, Pal Road-342001
Jodhpur
RAJASTHAN |
sunil.dadhich6@gmail.com |
| Dr Prabha Sawant |
L.T.M. Medical College & General Hospital, Mumbai |
Dept. of Gastroenterology,L.T.M. Medical College & General Hospital, Sion-400022
Mumbai
MAHARASHTRA |
022-2407638
022-24044154
prabhasawant@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee - Aditya (DrAtulShende) |
Approved |
| Independent Ethics Committee - Aditya (DrManishBhatnagar) |
Approved |
| Independent Ethics Committee - Aditya (DrSandeepNijhawan) |
Approved |
| Independent Ethics Committee - Aditya (DrSunilDadhich) |
Approved |
| Independent Ethics Committee - Aditya (DrSunilGupta) |
Approved |
| Institutional Ethics Committee - LTMMC&GH (DrPrabhaSawantSion) |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K297||Gastritis, unspecified, Peptic ulcer & Acute gastritis, (2) ICD-10 Condition: K279||Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Omeprazole 20 mg capsules |
One capsule once daily for 4 weeks |
| Intervention |
Revaprazan 200 mg tablets |
One tablet once daily for 4 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
19.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex of 19 to 75 years of age.
2. Established diagnosis of peptic ulcer or acute gastritis.
3. Informed consent of the patient/relative. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy or Lactation.
2. Clinically significant disorder of liver, kidney, cardiovascular system, respiratory system, endocrine system and CNS.
3. Not eligible to undergo endoscopy.
4. Zollinger-Ellison syndrome.
5. Patients requiring use of any unacceptable concomitant medications
6. Patients with any other serious concurrent illness or malignancy.
7. Patients with continuing history of alcohol and / or drug abuse.
8. Participation in another clinical trial in the past 3 months. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The endoscopic improvement rate |
Baseline & 4 Weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Improvement in total score of GI symptoms |
0, 1, 2, 3 & 4 weeks |
|
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)
|
16/06/2010 |
| 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="7"
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 an open label, comparative, multicentric study comparing the safety and efficacy of Revaprazan 200 mg tablets and Omeprazole 20 mg capsules given once daily each for 4 weeks; in 200 patients with Peptic Ulcer or Acute Gastritis that will be conducted in India. The primary outcome measures will be the endoscopic improvement rate and symptomatological improvement rate at the end of study.. |