Comparison of Antisecretory Effect of a Single Dose of Rabeprazole 20 mg and Omeprazole 20 mg in Obese Subjects
Information source: Nantes University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux
Intervention: Omeprazole (Drug); Rabeprazole (Drug); Lactose (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Nantes University Hospital Official(s) and/or principal investigator(s): Stanislas Bruley des Varannes, MD, Principal Investigator, Affiliation: CHU de Nantes
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.
Clinical Details
Study design: N/A
Primary outcome: 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
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
CHU de Nantes, Nantes 44093, France
Additional Information
Starting date: April 2010
Last updated: September 23, 2010
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