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

Phase 2

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Drug: Omeprazole; Drug: Rabeprazole; Drug: Lactose

• Registration Number: NCT01136317
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-23
• Last Update Posted: 2010-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Omeprazole	Omeprazole	-
Rabeprazole	Rabeprazole	-
Placebo	Lactose	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France