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

NCT ID: NCT01136317

Last Updated: 2010-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroesophageal Reflux

Study Groups

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Omeprazole

Group Type EXPERIMENTAL

Omeprazole

Intervention Type DRUG

Rabeprazole

Group Type EXPERIMENTAL

Rabeprazole

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Lactose

Intervention Type DRUG

Interventions

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Omeprazole

Intervention Type DRUG

Rabeprazole

Intervention Type DRUG

Lactose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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CHU de Nantes

Principal Investigators

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Stanislas Bruley des Varannes, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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CHU de Nantes

Nantes, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 25027286 (View on PubMed)

Other Identifiers

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BRD10/1-P

Identifier Type: -

Identifier Source: org_study_id