| CTRI Number |
CTRI/2012/04/002575 [Registered on: 16/04/2012] Trial Registered Prospectively |
| Last Modified On: |
16/04/2012 |
| 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 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 in the treatment of gastroesophageal reflux disease (GERD): a randomized, open label, comparative, multicentric study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SP/IP-026/0610; V-00/ Jun 06, 2010; A-01/ Feb 08,2012 |
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
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prasanna S Shah |
Aayush GI care |
B-41 Gita, Pandita Ramabai Road.
Gamdevi, Mumbai-40007
Mumbai
MAHARASHTRA |
02223673583
drpsshah@yahoo.co.in |
| Dr Raj Bhagat |
Dr. Bhagat’s Allergy- Asthma Clinic and Respiratory Care Centre |
Pathik B/h Paldi Bus Stand, Dashporwad Society, Paldi, Ahmedabad-380007, Gujarat
Ahmadabad
GUJARAT |
07926574746
rajpurvi@yahoo.com |
| Dr Dhiren Pipalia |
Dr. Kamdar’s Surgical Clinic |
206, Laxmi Shopping Centre, Hirachand Desai Road, Ghatkopar (W) Mumbai-400 086.Maharashatra.
Mumbai
MAHARASHTRA |
02225152749
dhpipalia@hotmail.com |
| Dr Chetan N Mehta |
Gastrocare clinic |
Polio clinic building, Opp. Balaji Mandir, Bhupendra Road, Rajkot-1
Rajkot
GUJARAT |
02812235010
mehtacn@hotmail.com |
| Dr Ajay Shah |
Krishna Hospital |
Jaypunj Complex, Opp. Shankarbhuvan, O/s. Shahpur Gate, Ahmedabad-380004
Ahmadabad
GUJARAT |
07925600305
ajoy45shah@yahoo.com |
| Dr Rahul V Pai |
Pai Clinic & Diagnostic Centre |
778/B-1, Abhinav Apartments,
Next to Congress House, Shivajinagar,
Pune – 411005, Maharashtra.
Pune
MAHARASHTRA |
02027290815
pairahul73@gmail.com |
| Dr Deepak B Patil |
Sai-krupa Hospital and Endoscopy Centre |
91/2, A, Dudhali, Kolhapur-416012. Maharashtra.
Kolhapur
MAHARASHTRA |
02312545821
drdbpatil@gmail.com |
| Dr Milind Yeole |
Vinod Memorial Hospital |
A-23, Geeta Complex, Kasturbha Society
Vishrantwadi, Pune- 15, Maharashtra
Pune
MAHARASHTRA |
02026696202
vmh_pune@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| COMSARTs Independent Ethics Committee, Mumbai for Dr Dhiren Pipalia |
Approved |
| COMSARTs Independent Ethics Committee, Mumbai for Dr Prasanna S Shah |
Approved |
| COMSARTs Independent Ethics Committee, Mumbai for Dr Milind Yeole |
Approved |
| COMSARTs Independent Ethics Committee, Mumbai for Dr Rahul V Pai |
Approved |
| Medilink Ethics Committee, Ahmedabad for Dr Ajay Shah |
Approved |
| Medilink Ethics Committee, Ahmedabad for Dr Raj Bhagat |
Approved |
| Medilink Ethics Committee, Ahmedabad for Dr. Chetan N Mehta |
Approved |
| Shree Mahalaxmi 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 |
BY-1023 (Pantoprazole 40mg) tablet |
The recommended dose is 1 tablet once daily in the morning during or before breakfast orally for 4 weeks. |
| Intervention |
IP-026 (FDC of Pantoprazole (40 mg) and Levosulpiride SR (75 mg)) capsule |
The recommended dose is 1 capsule once daily before meals orally for 4 weeks. |
|
|
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 Pantoprazole 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)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/04/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 meal for 4 weeks and comparator drug (proton pump
inhibitor) tablet is once daily in the morning or before breakfast for 4 weeks
in 200 patients with Gastro esophageal reflux disease that will be conducted in
eight 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 week 4 (Visit 3). Evaluation of Clinical global impression on
improvement will be done on week 2 (Visit 2) and end of study week 4 (Visit 3).
Evaluation of Adverse event/s will be assessed on every visit. This is not a global
study. |