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Rebamipide in Combination With Esomeprazole in the Management of Asian Patients With Functional Dyspepsia

NCT02134405 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-01-05

No results posted yet for this study

Summary

This is a multi-Asian-centre randomised controlled trial of Rebamipide alone vs Rebamipide with Esomeprazole in the treatment of adult patients with Functional Dyspepsia. The hypothesis is that a combination therapy is superior to mono-therapy in the control of patients' symptoms and quality of life improvement.

Conditions

  • Dyspepsia

Interventions

DRUG

Rebamipide

Rebamipide 100mg tid

DRUG

Placebo (for Esomeprazole)

Sugar pill manufactured to mimic Esomeprazole

DRUG

Esomeprazole

Esomeprazole tablets 20mg o.d. for 8 weeks

Sponsors & Collaborators

  • Zhejiang Provincial Hospital of TCM

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER

  • University of Malaya

    lead OTHER

Principal Investigators

  • Sanjiv Mahadeva, MRCP, MD · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-06-30
Completion
2016-12-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02134405 on ClinicalTrials.gov