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

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01136317
• Collaborator: (none)
• Location: 1
• Arms: 3
• Duration (Months): 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux	Drug: Omeprazole; Drug: Rabeprazole; Drug: Lactose	Phase 2

Study Design

• Study Type: Interventional
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Omeprazole	Drug: Omeprazole
Experimental: Rabeprazole	Drug: Rabeprazole
Placebo Comparator: Placebo	Drug: Lactose

Outcome Measures

Primary Outcome Measures

1. 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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nantes	Nantes		France	44093

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Principal Investigator: Stanislas Bruley des Varannes, MD, CHU de Nantes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01136317
• Other Study ID Numbers: BRD10/1-P
• First Posted: Jun 3, 2010
• Last Update Posted: Sep 24, 2010
• Last Verified: Sep 1, 2010

• Additional relevant MeSH terms: Gastroesophageal Reflux; Omeprazole; Rabeprazole

Study Results

No Results Posted as of Sep 24, 2010