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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01136317
First Posted: June 3, 2010
Last Update Posted: September 24, 2010
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.
Information provided by:
Nantes University Hospital
  Purpose
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 Intervention Phase
Gastroesophageal Reflux Drug: Omeprazole Drug: Rabeprazole Drug: Lactose Phase 2

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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.

Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omeprazole Drug: Omeprazole
Experimental: Rabeprazole Drug: Rabeprazole
Placebo Comparator: Placebo Drug: Lactose

  Eligibility

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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.
  Contacts and Locations
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
  More Information

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 Submitted: June 2, 2010
First Posted: June 3, 2010
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