| CTRI Number |
CTRI/2012/03/002508 [Registered on: 21/03/2012] Trial Registered Prospectively |
| Last Modified On: |
13/09/2012 |
| 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 study the efficacy and safety of fixed dose combination of a proton pump inhibitor and a dopamine antagonist in the treatment of gastroesophageal reflux disease. |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of fixed dose combination of a proton pump inhibitor and a dopamine (DA2) antagonist in the treatment of gastroesophageal reflux disease (GERD): a randomized, open label, comparative, multicentric study. |
| Trial Acronym |
GERD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SP/ELSE/0310; V-00/Mar 23, 2010; A-01/Jan 07, 2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Surendra Borgharkar |
| Designation |
Medical Advisor |
| Affiliation |
Sun Pharmaceutical Industries Ltd. |
| Address |
Sun Pharmaceutical Industries Ltd.
Acme Plaza, Andheri Kurla Road, Andheri East, Mumbai – 400059. Maharashtra. India.
Mumbai
MAHARASHTRA
400059
India |
| Phone |
02266969696 |
| Fax |
02228212010 |
| Email |
medical.services@sunpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surendra Borgharkar |
| Designation |
Medical Advisor |
| Affiliation |
Sun Pharmaceutical Industries Ltd. |
| Address |
Sun Pharmaceutical Industries Ltd.
Acme Plaza, Andheri Kurla Road, Andheri East, Mumbai – 400059. Maharashtra. India.
Mumbai
MAHARASHTRA
400059
India |
| Phone |
02266969696 |
| Fax |
02228212010 |
| Email |
medical.services@sunpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surendra Borgharkar |
| Designation |
Medical Advisor |
| Affiliation |
Sun Pharmaceutical Industries Ltd. |
| Address |
Sun Pharmaceutical Industries Ltd.
Acme Plaza, Andheri Kurla Road, Andheri East, Mumbai – 400059. Maharashtra. India.
Mumbai
MAHARASHTRA
400059
India |
| Phone |
02266969696 |
| Fax |
02228212010 |
| Email |
medical.services@sunpharma.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharmaceutical Industries Ltd.
Acme Plaza, Andheri Kurla Road, Andheri East,
Mumbai – 400059. Maharashtra. India.
|
|
|
Primary Sponsor
|
| Name |
Sun Pharmaceutical Industries Ltd |
| Address |
Acme Plaza, Andheri Kurla Road, Andheri East,
Mumbai – 400059. Maharashtra. India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prashant Mahajan |
Dr Prashant Mahajan’s Clinic |
Department of Medicine, A 1/3, Ground Floor, Shantiban,
Off Chapekar Chowk, Next to PNG Jewellers, Chinchwad, Pune-411033.
Pune
MAHARASHTRA |
9881504812
drmahajanp@yahoo.co.in |
| Dr Rajiv S Tungare |
Heart and Diabetes Care Centre |
Department of Medicine, 104, Gulmohar Complex, Opp. Anupam Cinema, Goregaon (East), Mumbai-400063. Maharashtra.
Mumbai
MAHARASHTRA |
02226862428
ilovemydoctor@hotmail.com |
| Dr Manish Agrawal |
Medilink Hospital |
Department of Medicine, Nr. Shyamal char Rasta, 132 ft. Ring road, Satellite, Ahmedabad-380015.
Ahmadabad
GUJARAT |
07926743051
medilinkhospital@yahoo.com |
| Dr Rahul V Pai |
Pai Clinic and Diagnostic Centre |
Department of Medicine, Apts,
778/B-1, Shivaji Nagar, Next to congress House, Pune-411005. Maharashatra
Pune
MAHARASHTRA |
02025534404
pairahul73@gmail.com |
| Dr Udaysingh V Patil |
PRATIBHA Digestive Disease & Endoscopy Centre |
Department of Gastroenterology, Civil Hospital Chowk, Ambedkar Road,
Sangli-416416, Maharashtra.
Sangli
MAHARASHTRA |
9890640126
udaysinh.pratibha@gmail.com |
| Dr Deepak B Patil |
Sai krupa Hospital and Endoscopy Centre |
Department of Gastroenterology, 91/2, A, Dudhali, Kolhapur 416012 Maharashtra.
Kolhapur
MAHARASHTRA |
02312545821
drdbpatil@gmail.com |
| Dr Manoj Chitale |
Shree Clinic |
Department of Medicine, Bele park, Pumping Station
Opp. Mama mungi office, Gangapur road, Nashik-5
Nashik
MAHARASHTRA |
02532582379
drcm@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| COMSARTs Independent Ethics Committee, Mumbai for Dr. Manoj Chitale |
Approved |
| COMSARTs Independent Ethics Committee, Mumbai for Dr. Prashant Mahajan |
Approved |
| COMSARTs Independent Ethics Committee, Mumbai for Dr. Rahul V. Pai |
Approved |
| COMSARTs Independent Ethics Committee, Mumbai for Dr. Rajiv S. Tungare |
Approved |
| Medilink Ethics Committee, Ahmedabad affiliated to Medilink hospital for Dr. Manish Agrawal |
Approved |
| Shree Mahalaxmi Independent Ethics Committee, Kolhapur for Dr. Udaysingh V. Patil |
Approved |
| Shree Mhalaxmi Independent Ethics Committee, Kolhapur for Dr. Deepak B. Patil |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
GASTROESOPHAGEAL REFLUX DISEASE (GERD), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
H199/18 (Esomeprazole 40mg) tablet |
The recommended dose is 1 tablet once daily in the morning before breakfast for 4 weeks orally. |
| Intervention |
IP-005 (FDC of Esomeprazole (40 mg) and Levosulpiride SR (75 mg)) capsule |
The recommended dose is 1 capsule once daily before breakfast for 4 weeks orally. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female patients aged between 18-70 years.
2.Patients with GERD (Gastro esophageal Reflux Disease).
3.Patients willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
2.Patients with peptic ulcer or Zollinger-Ellison syndrome.
3.Patients with previous surgery of gastrointestinal tract excluding appendectomy, cholecystectomy and polypectomy.
4.Patients with other diseases or conditions such as scleroderma, pancreatitis, cancer, Parkinson’s disease, epilepsy, mania and inflammatory bowel disease.
5.Patients with any severe illnesses (hepatic, renal, cardiac).
6.Patients with uncontrolled diabetes, hypertension, clotting disorder.
7.History of heavy smoking (> 20 cigarettes per day).
8.Hypersensitive to either esomeprazole or levosulpiride.
9.Recent (in the past two years) drug dependence or abuse.
10.History of non-compliance to medical regimens or those patients unwilling to comply with the study protocol.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Average change from baseline to end of study of following symptoms by Likert scale:
•Heart burn
•Epigastric Pain
•Nausea
|
Baseline Visit (day 0), week 2 & week 4. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Average change from baseline to end of study of following symptoms evaluated by ‘Present (0)’ or ‘Absent (1)’:
•Dysphagia
•Chest pain
•Dry cough
2.Evaluation CGI-S and CGI-I
|
1.Baseline Visit (day 0), week 2 & week 4.
2.For CGI-S, at Baseline visit (day 0) and week 4 only and for CGI-I, at week 2 & week 4 only.
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
21/03/2012 |
| 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
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
study is a randomized, open label, parallel group, multi-centre study comparing
the safety and efficacy of Fixed dose combination of a proton pump inhibitor and
a prokinetic drug versus same proton pump inhibitor in GERD. Dosing schedule of fixed dose combination capsule
is once daily before breakfast for 4 weeks and comparator drug (proton pump
inhibitor) tablet is once daily before breakfast for 4 weeks in 200 patients
with Gastro esophageal reflux disease that will be conducted in nine centers in
India. The primary outcome measure will be average change from baseline to end
of study on symptom of heart burn, epigastric pain and nausea. The secondary
outcome will be average change form baseline to end of study on symptoms of
Dysphagia, Chest pain, Dry cough. Evaluation of Clinical global impression on
severity (CGI-S) will be done on baseline visit and end of study. Evaluation of
Clinical global impression on improvement will be done on week 2 (Visit 2) and
end of study. Evaluation of Adverse event/s will be assessed on every visit. This is not a global
study. |