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

Phase 3

• Conditions: Gastroesophageal Reflux Disease

• Registration Number: CTRI/2010/091/002965
• Lead Sponsor: M/s. Acme Formulation Pvt. Ltd

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

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy parameter is the evaluation of GERD symptom score on day 14 & day 28.	on Day 14 and Day 28

Secondary Outcome Measures

Name	Time	Method
oIndividual mean frequency of each GERD symptom [Time Frame: 4 weeks] oIndividual mean score for respiratory symptoms [ Time Frame: 4 weeks ] oChange in endoscopy results at end of study in patients with a second endoscopy	4 weeks

Trial Locations

Locations (4)

Clinic, Bhavnagar, Rajivoza59@hotmail.com; 🇮🇳 Bhavnagar, GUJARAT, India

Clinic, Nashik, sudhakar.vyavahare@yahoo.com; 🇮🇳 Nashik, MAHARASHTRA, India

Gillurkar Multispeciality Hospital Pvt. Ltd., Nagpur, drkirtilata@yahoo.com; 🇮🇳 Nagpur, MAHARASHTRA, India

NHL Medical College & Hospital, Ahmedabad, Rajpurvi@yahoo.com; 🇮🇳 Ahmadabad, GUJARAT, India

Clinic, Bhavnagar, Rajivoza59@hotmail.com

🇮🇳Bhavnagar, GUJARAT, India

Dr. Rajiv Oza

Principal investigator

Rajivoza59@hotmail.com