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

Primary Purpose

Gastroesophageal Reflux

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Omeprazole
Rabeprazole
Lactose
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Gastroesophageal Reflux

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • CHU de Nantes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Omeprazole

Rabeprazole

Placebo

Arm Description

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
June 2, 2010
Last Updated
September 23, 2010
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01136317
Brief Title
Comparison of Antisecretory Effect of a Single Dose of Rabeprazole 20 mg and Omeprazole 20 mg in Obese Subjects
Acronym
Oberab
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux

7. Study Design

Study Phase
Phase 2

8. Arms, Groups, and Interventions

Arm Title
Omeprazole
Arm Type
Experimental
Arm Title
Rabeprazole
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Intervention Type
Drug
Intervention Name(s)
Rabeprazole
Intervention Type
Drug
Intervention Name(s)
Lactose
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanislas Bruley des Varannes, MD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25027286
Citation
Belhocine K, Vavasseur F, Volteau C, Flet L, Touchefeu Y, Bruley des Varannes S. Controlling on-demand gastric acidity in obese subjects: a randomized, controlled trial comparing a single dose of 20 mg rabeprazole and 20 mg omeprazole. BMC Gastroenterol. 2014 Jul 15;14:128. doi: 10.1186/1471-230X-14-128.
Results Reference
derived

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

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