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

NCT02134405 | Unknown Phase 4

• 1 other identifier: 037-OTC-1203i
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

functional dyspepsia; symptoms; proton pump inhibitor; gastritis

Outcome Measures

Primary Outcomes (1)

• Dyspepsia symptoms

  To assess the efficacy of Rebamipide in combination with Esomeprazole in the improvement of symptoms of Functional Dyspepsia in Asian patients compared to Esomeprazole alone.

  8 weeks

Secondary Outcomes (1)

• quality of life

  8 weeks

Other Outcomes (2)

• Financial costs

  12 weeks

• Adverse events

  12 weeks

Study Arms (2)

Rebamipide and Esomeprazole

EXPERIMENTAL

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

Drug: Rebamipide; Drug: Esomeprazole

Rebamipide and placebo

ACTIVE COMPARATOR

Placebo drug with Rebamipide 100mg tid

Drug: Rebamipide; Drug: Placebo (for Esomeprazole)

Interventions

Rebamipide DRUG

Rebamipide 100mg tid

Also known as: Mucosta

Rebamipide and Esomeprazole; Rebamipide and placebo

Placebo (for Esomeprazole) DRUG

Sugar pill manufactured to mimic Esomeprazole

Also known as: placebo

Rebamipide and placebo

Esomeprazole DRUG

Esomeprazole tablets 20mg o.d. for 8 weeks

Also known as: Nexium

Rebamipide and Esomeprazole

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Functional Dyspepsia using Rome III diagnostic criteria
• Age ≥ 18 years, \< 80 years
• Subject who has ability to provide written informed consent and willingness to comply with the requirement of the protocol
• Able to communicate in English, Malay or Mandarin languages
• Patients on prior dyspepsia treatment - after washout period of 1 week

You may not qualify if:

• Patients with known hypersensitivity to Rebamipide and/or Esomeprazole and any other component of these formulations.
• 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
• 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
• Patients consuming regular Aspirin or NSAIDs (except low-dose Aspirin at a dose of 325 mg/day or less for cardiovascular prophylaxis)
• History of erosive esophagitis, peptic ulcer disease within 1 year prior to the screening
• History of gastrointestinal (GI) malignancy, primary esophageal motility disorder, documented upper GI surgery
• Patients with any hepatobiliary or pancreatic diseases
• Patients with severe depression, anxiety, or other psychological disorder
• Patients with any terminal disease
• Presence of irritable bowel syndrome (Rome III criteria) or inflammatory bowel disease (IBD)
• 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)
• 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
• Unable to communicate in English, Malay, or Mandarin
• Other conditions determined by the investigator to be inappropriate for this clinical study

Sponsors & Collaborators

• University of Malaya: lead
• Zhejiang Provincial Hospital of TCM: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

RECRUITING

MeSH Terms

Conditions

Dyspepsia; Gastritis

Interventions

rebamipide; Esomeprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sanjiv Mahadeva, MRCP, MD

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjiv Mahadeva, MRCP, MD

CONTACT

60122171743; sanjiv@ummc.edu.my

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 9, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 5, 2016

Record last verified: 2016-01

Locations

MY (1)