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

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.

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Nantes

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omeprazole

Drug

rabeprazole

Drug

lactose

Drug

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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: Oberab

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jun 3, 2010
Registry last updated: Sep 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed