Comparison of Antisecretory Effect of a Single Dose of Rabeprazole 20 mg and Omeprazole 20 mg in Obese Subjects

Nantes University Hospital

Overview

This study aims to determine, in obese subjects, the antisecretory effect of a single dose of placebo, rabeprazole 20 mg and omeprazole 20 mg using 24h gastric pH monitoring, in a prospective, monocentre, randomized manner. Monitorings are separated between 6 and10 days. The main outcome criteria of analysis is the percentage of time with gastric pH above 3 during 24hours.

Study Type

INTERVENTIONAL

Conditions

Gastroesophageal Reflux

Interventions

OmeprazoleDRUG

RabeprazoleDRUG

LactoseDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Helicobacter negative obese subject (BMI 30 to 40), * 18 to 55 years old, * normal hepatic biology and morphology (echography) * Contraceptive methods in women. Exclusion Criteria: * Subjects with previous abdominal surgery, with diabetic or immunosuppressive treatment.

Locations (1)

CHU de Nantes

Nantes, France

Outcomes

Primary Outcomes

In order to measure antisecretory effect, the main outcome criteria of analysis will be the percentage of time with gastric pH above 3 and measured during 24hours following rabeprazole administration in comparison with omeprazole administration.

Data from ClinicalTrials.gov

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