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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• 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: Interventional
• Study Design: Not specified