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

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ClinicalTrials.gov Identifier: NCT01136317
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : September 24, 2010
Sponsor:
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

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01136317


Locations
France
CHU de Nantes
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Stanislas Bruley des Varannes, MD CHU de Nantes

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr Stanislas Bruley des Varannes, CHU de Nantes
ClinicalTrials.gov Identifier: NCT01136317     History of Changes
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:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole
Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action