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:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01136317
First received: June 2, 2010
Last updated: September 23, 2010
Last verified: September 2010
  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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Pr Stanislas Bruley des Varannes, CHU de Nantes
ClinicalTrials.gov Identifier: NCT01136317     History of Changes
Other Study ID Numbers: BRD10/1-P
Study First Received: June 2, 2010
Last Updated: September 23, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014