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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01136317
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : September 24, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Drug: Omeprazole Drug: Rabeprazole Drug: Lactose Phase 2

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Study Type : Interventional  (Clinical Trial)
Study Start Date : April 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

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

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.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01136317

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CHU de Nantes
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
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Principal Investigator: Stanislas Bruley des Varannes, MD CHU de Nantes
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pr Stanislas Bruley des Varannes, CHU de Nantes Identifier: NCT01136317    
Other Study ID Numbers: BRD10/1-P
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: September 24, 2010
Last Verified: September 2010
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action