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

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 2

Conditions: Gastroesophageal Reflux

Treatments: Drug: Lactose; Drug: Omeprazole; Drug: Rabeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01136317

BRD10/1-P

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

0 participants in 3 patient groups, including a placebo group

Omeprazole

Experimental group

Treatment:

Drug: Omeprazole

Rabeprazole

Experimental group

Treatment:

Drug: Rabeprazole

Placebo

Placebo Comparator group

Treatment:

Drug: Lactose