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

Gastroesophageal Reflux Clinical Trial

— Oberab  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136317
• Other study ID #: BRD10/1-P
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2010
• Last updated: September 23, 2010
• Start date: April 2010
• Est. completion date: July 2010

Study information

• Verified date: September 2010
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• Omeprazole

• Rabeprazole

• Lactose

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.