| CTRI Number |
CTRI/2009/091/000682 [Registered on: 08/12/2009] |
| 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 the effects of two drugs, fixed dose combination capsules of Omeprazole & Cinitapride ER and Omeprazole capsules in patients with non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD) |
Scientific Title of Study
Modification(s)
|
An open label comparative, multicentric study to assess the efficacy and safety of fixed dose combination capsules of Omeprazole & Cinitapride ER in comparison with Omeprazole capsules in patients suffering from non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD) |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 08-15 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head-Regulatory Affairs |
| 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 |
Medical Advisor & Head-Regulatory Affairs |
| 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
Public Query
Modification(s)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head-Regulatory Affairs |
| 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)
|
| Cadila Healthcare Ltd.
Zydus Tower, Satellite Cross Roads
Ahmadabad 380015
GUJARAT |
|
Primary Sponsor
Modification(s)
|
| Name |
Cadila Healthcare Ltd |
| Address |
Zydus Tower, Satellite Cross Roads
Ahmadabad 380015
GUJARAT
|
| 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 = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Panna Kamdar |
Govt. Medical College & Sir T. Hospital, Bhavnagar |
Dept. of Medicine,Govt. Medical College & Sir T. Hospital, Bhavnagar-
Bhavnagar
GUJARAT |
drpam2007@hotmail.com |
| Dr. Parul Bhatt |
Govt. Medical College, Surat |
Dept. of Medicine,Govt. Medical College-
Surat
GUJARAT |
drparulbhatt@yahoo.co.in |
| Dr. P. G. Raman |
Mayur Hospital & Research Centre, Indore |
Consultant Physician,Mayur Hospital & Research Centre-
Indore
MADHYA PRADESH |
drpgraman@yahoo.com |
| Dr. Raghvindra Chowdhary |
S.P. Medical College and A.G. Hospitals, Bikaner |
Dept. of Medicine,S.P. Medical College and A.G. Hospitals-
Bikaner
RAJASTHAN |
drraghven_10@yahoo.com |
| Dr Dimple Patel |
Sheth Shri Pukhraj Raichand General Hospital, Ahmedabad |
Consultant Physician,Sheth Shri Pukhraj Raichand General Hospital, Sabarmati, -380005
Ahmadabad
GUJARAT |
07927506861
drtusharpatel@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee - S.P. Medical College & A.G. Hospitals, Bikaner |
Approved |
| Human Research Ethics Committee - Govt. Medical College & New Civil Hospital, Surat |
Approved |
| Independent Ethics Committee - Aditya |
Approved |
| Independent Ethics Committee - Aditya |
Approved |
| Institutional Review Board (Human Ethics Committee) - Govt. Medical College, Bhavnagar |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K30||Functional dyspepsia, (2) ICD-10 Condition: K219||Gastro-esophageal reflux disease without esophagitis, Non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD), |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Fixed-dose combination capsules of Omeprazole 20 mg & Cinitapride ER 3 mg |
Once in a day before meals for 4 weeks |
| Comparator Agent |
Omeprazole 20 mg capsules |
Once in a day before meals for 4 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex 18 years of age (no upper age limit was mentioned in our Protocol for this clinical trial).
2. Established diagnosis of non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD) with gastrointestinal symptoms of at least moderate intensity.
3. Informed consent of the patient / relative. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy and/or Lactation.
2. Patients with an increased gastrointestinal motility e.g. in patients with gastrointestinal hemorrhage, mechanical obstruction or perforation.
3. Patients with ulcerative dyspepsia and/or ulcerative gastritis.
4. Patients with severe cardiac, pulmonary, hepatic or renal disease.
5. Patients on concomitant medications known to prolong QT interval.
6. Patients on concomitant medications known to affect action of Cinitapride like anticholinergic agents such as scopolamine, psychotropic drugs, other dopaminergic agents, or hormones.
7. Patients with known hypersensitivity to Omeprazole or Cinitapride or any other proton pump inhibitors or any other prokinetic agents.
8. Patients with any other serious concurrent illness or malignancy.
9. Patients with continuing history of alcohol and / or drug abuse.
10. 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 change in the mean intensity score of the symptoms (overall and individual) at the end of the study (Week 4) as compared to the baseline (prior to initiation of the therapy i.e. Week 0) |
1,2,3 & 4 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
(1) Improvement in the mean intensity score of the symptoms (overall and individual) as estimated on a weekly basis.
(2) Percentage of patients experiencing complete resolution of symptoms of reduced gastrointestinal motility at the end of the study i.e. 4 weeks.
(3) Percentage of patients having endoscopic healing on upper G.I. endoscopy, if done.
(4) Overall assessment of efficacy to the study medication at the end of the study |
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)
|
18/04/2009 |
| 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="10"
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 fixed-dose combination capsules of Omeprazole & Cinitapride ER and Omeprazole capsules once daily before meals each for 4 weeks in 200 patients with non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD) that will be conducted in India. The primary outcome measures will be the change in the mean intensity score of the symptoms (overall and individual) at the end of the study as compared to the baseline. |