None listed
Conditions
Interventions
Intervention1: FDC of Rabeprazole Sodium 20 mg + Levosulpiride SR 75 mg: 20 mg and 75 mg
Control Intervention1: Oral tablets of Rabeprazole Sodium 20 mg: 20 mg
Sponsors
M/s. Acme Formulation Pvt. Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy parameter is the evaluation of GERD symptom score on day 14 & day 28.Timepoint: on Day 14 and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Timepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactDr. Raj G Bhagat
Outcome results
None listed