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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

Page last updated: August 23, 2015

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