| CTRI Number |
CTRI/2010/091/002965 [Registered on: 11/11/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of fixed-dose combination of Rabeprazole Sodium 20 mg and Levosulpiride SR 75 mg oral capsules in patients with Gastroesophageal Reflux Disease |
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Scientific Title of Study
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?A Multicentric, Open-label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Safety and Efficacy of the fixed-dose combination of Rabeprazole Sodium 20 mg and Levosulpiride SR 75 mg oral capsules versus Rabeprazole Sodium 20 mg oral tablet in patients with Gastroesophageal Reflux Disease? |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Acme/CT/Rabes_Levosr/082010 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Raj G Bhagat |
| Designation |
|
| Affiliation |
|
| Address |
NHL Medical College & Hospital, Ahmedabad
Ahmadabad
GUJARAT
India |
| Phone |
|
| Fax |
|
| Email |
Rajpurvi@yahoo.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Raj G Bhagat |
| Designation |
|
| Affiliation |
|
| Address |
NHL Medical College & Hospital, Ahmedabad
Ahmadabad
GUJARAT
India |
| Phone |
|
| Fax |
|
| Email |
Rajpurvi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Raj G Bhagat |
| Designation |
|
| Affiliation |
|
| Address |
NHL Medical College & Hospital, Ahmedabad
Ahmadabad
GUJARAT
India |
| Phone |
|
| Fax |
|
| Email |
Rajpurvi@yahoo.com |
|
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Source of Monetary or Material Support
|
| M/s. Acme Formulation Pvt. Ltd
Ropar Road, Nalagarh,
Dist. Solan, H.P.-174 101
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Primary Sponsor
|
| Name |
M/s. Acme Formulation Pvt. Ltd |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Rajiv Oza |
Clinic, Bhavnagar, Rajivoza59@hotmail.com |
Clinic, Bhavnagar, Rajivoza59@hotmail.com,-
Bhavnagar
GUJARAT |
Rajivoza59@hotmail.com |
| Dr. Sudhakar Vyavahare |
Clinic, Nashik, sudhakar.vyavahare@yahoo.com |
Clinic, Nashik, sudhakar.vyavahare@yahoo.com,-
Nashik
MAHARASHTRA |
sudhakar.vyavahare@yahoo.com |
| Dr. Kirtilata Gillurkar |
Gillurkar Multispeciality Hospital Pvt. Ltd., Nagpur, drkirtilata@yahoo.com |
Gillurkar Multispeciality Hospital Pvt. Ltd., Nagpur, drkirtilata@yahoo.com,-
Nagpur
MAHARASHTRA |
drkirtilata@yahoo.com |
| Dr. Raj G Bhagat |
NHL Medical College & Hospital, Ahmedabad, Rajpurvi@yahoo.com |
NHL Medical College & Hospital, Ahmedabad, Rajpurvi@yahoo.com,-
Ahmadabad
GUJARAT |
Rajpurvi@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
| COMSARTs |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Gastroesophageal Reflux Disease, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Rabeprazole Sodium 20 mg + Levosulpiride SR 75 mg |
20 mg and 75 mg |
| Comparator Agent |
Oral tablets of Rabeprazole Sodium 20 mg |
20 mg |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
 All subjects with duly filled and signed in ICFs [Informed Consent Forms]
 Adult males or females, age 18-65 years (inclusive).
 Gastroesophageal Reflux Disease with endoscopically confirmed GERD by positive endoscopic evidence of reflux related esophagitis.
 Sexually active female patients of childbearing potential must practice adequate contraception during the treatment period and for 6 months after discontinuation of therapy. A pregnancy test obtained at entry prior to the initiation of treatment must by negative. Female patients must not be breast-feeding.
|
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| ExclusionCriteria |
| Details |
 Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods
 History or presence of upper gastrointestinal anatomic or motor disorders.
 Acute peptic ulcer and/or ulcer complications
 History of hematemesis within last 3 months of therapy.
 Known current or active cow` s milk allergy
 Any major hematologic, hepatic, metabolic, gastrointestinal or endocrine disorder requiring any other anti-GERD medication
 Cardiac surgery within 30 days of potential study enrollment, excluding percutaneous coronary interventions.
 History of a myocardial infarction within 30 days of potential study enrollment.
 History of hypersensitivity and/or idiosyncratic reaction to benzimidazoles.
 History of drug or medication abuse within the past year, or current alcohol abuse.
 Previous participation in this or any other Rabeprazole Sodium 20 mg clinical trial.
 Terminally ill or moribund condition with little chance of short term survival.
 Serum creatinine >3.5 mg/dL
 Concomitant diseases such as malignancy, HIV.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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On-site computer system |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| The primary efficacy parameter is the evaluation of GERD symptom score on day 14 & day 28. |
on Day 14 and Day 28 |
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Secondary Outcome
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| Outcome |
TimePoints |
| o Individual mean frequency of each GERD symptom [Time Frame: 4 weeks]
o Individual mean score for respiratory symptoms [ Time Frame: 4 weeks ]
o Change in endoscopy results at end of study in patients with a second endoscopy
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4 weeks |
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Target Sample Size
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Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/11/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
This study is A Multicentric, Open-label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Safety and Efficacy of the fixed-dose combination of Rabeprazole Sodium 20 mg and Levosulpiride SR 75 mg oral capsules versus Rabeprazole Sodium 20 mg oral tablet in patients with Gastroesophageal Reflux Disease that will be conducted in four centres in India |