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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Malaya
• Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University; Zhejiang Provincial Hospital of TCM
• Treatments: Esomeprazole; Rebamipide

Criteria

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