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

Dyspepsia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: 1. Patients diagnosed with Functional Dyspepsia using Rome III diagnostic criteria 2. Age ≥ 18 years, < 80 years 3. Subject who has ability to provide written informed consent and willingness to comply with the requirement of the protocol 4. Able to communicate in English, Malay or Mandarin languages 5. Patients on prior dyspepsia treatment - after washout period of 1 week Exclusion Criteria: 1. Patients with known hypersensitivity to Rebamipide and/or Esomeprazole and any other component of these formulations. 2. Pregnant, nursing, and childbearing potential women who is unwilling to effective contraception; for example, oral contraceptives, hormonal methods, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods (i.e., condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilization, and true abstinence 3. Presence of family history of GI malignancy or alarm features suggested malignancy - e.g. Unintentional weight loss (≥ 10% of body weight in recent 6 months), GI bleeding 4. Patients consuming regular Aspirin or NSAIDs (except low-dose Aspirin at a dose of 325 mg/day or less for cardiovascular prophylaxis) 5. History of erosive esophagitis, peptic ulcer disease within 1 year prior to the screening 6. History of gastrointestinal (GI) malignancy, primary esophageal motility disorder, documented upper GI surgery 7. Patients with any hepatobiliary or pancreatic diseases 8. Patients with severe depression, anxiety, or other psychological disorder 9. Patients with any terminal disease 10. Presence of irritable bowel syndrome (Rome III criteria) or inflammatory bowel disease (IBD) 11. Necessary to have a continuous concomitant treatment with sucralfate, quinidine, warfarin, phenytoin, bisphosphonates, methotrexate, ketoconazole, fluconazole, itaconazole, diazepam, anti-cholinergics, H2RAs, PPIs (except study drug), prokinetics, and/or NSAIDs (except topical use of NSAIDs; in systemic NSAIDs ≤2 days/week) 12. Use of PPIs (except study drug), H2RAs, prokinetics, antibiotics (except topical use), misoprostol, or bismuth compounds within 1 week prior to the screening, and who were taking antibiotics used to eradicate Helicobacter pylori within 4 weeks prior to the screening 13. Unable to communicate in English, Malay, or Mandarin 14. Other conditions determined by the investigator to be inappropriate for this clinical study

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?


Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:RebamipideRebamipide 100mg tid

Drug:Placebo (for Esomeprazole)Sugar pill manufactured to mimic Esomeprazole

Drug:EsomeprazoleEsomeprazole tablets 20mg o.d. for 8 weeks

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Rebamipide and EsomeprazoleRebamipide tablets 100mg tid for 8 weeks Esomeprazole tablets 20mg od for 8 weeks

Rebamipide and placeboPlacebo drug with Rebamipide 100mg tid

Study Status

Unknown status

Start Date: August 2014

Completed Date: December 2016

Phase: Phase 4

Type: Interventional


Primary Outcome: Dyspepsia symptoms

Secondary Outcome: quality of life

Study sponsors, principal investigator, and references

Principal Investigator: Sanjiv Mahadeva, MRCP, MD

Lead Sponsor: University of Malaya

Collaborator: Zhejiang Provincial Hospital of TCM

More information:

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