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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02134405
Recruitment Status : Unknown
Verified January 2016 by University of Malaya.
Recruitment status was:  Recruiting
First Posted : May 9, 2014
Last Update Posted : January 5, 2016
Sponsor:
Collaborators:
Zhejiang Provincial Hospital of TCM
Second Affiliated Hospital, School of Medicine, Zhejiang University
Information provided by (Responsible Party):
University of Malaya

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.

Condition or disease Intervention/treatment Phase
Dyspepsia Drug: Rebamipide Drug: Placebo (for Esomeprazole) Drug: Esomeprazole Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rebamipide in Combination With Esomeprazole in the Management of Asian Patients With Functional Dyspepsia: a Multi-national, Randomised, Double-blind, Placebo-controlled Study
Study Start Date : August 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Experimental: Rebamipide and Esomeprazole
Rebamipide tablets 100mg tid for 8 weeks Esomeprazole tablets 20mg od for 8 weeks
Drug: Rebamipide
Rebamipide 100mg tid
Other Name: Mucosta

Drug: Esomeprazole
Esomeprazole tablets 20mg o.d. for 8 weeks
Other Name: Nexium

Active Comparator: Rebamipide and placebo
Placebo drug with Rebamipide 100mg tid
Drug: Rebamipide
Rebamipide 100mg tid
Other Name: Mucosta

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




Primary Outcome Measures :
  1. Dyspepsia symptoms [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. quality of life [ Time Frame: 8 weeks ]
    i. To assess the efficacy of Rebamipide in combination with Esomeprazole in the improvement of quality of life in Asian patients with Functional Dyspepsia compared to Esomeprazole alone


Other Outcome Measures:
  1. Financial costs [ Time Frame: 12 weeks ]
    To assess the cost-effectiveness of Rebamipide in combination with Esomeprazole compared to Esomeprazole alone after 8, 12 weeks of treatment

  2. Adverse events [ Time Frame: 12 weeks ]
    To assess the safety of Rebamipide in combination with Esomeprazole in adults with functional dyspepsia after 8 weeks of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134405


Contacts
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Contact: Sanjiv Mahadeva, MRCP, MD 60122171743 sanjiv@ummc.edu.my

Locations
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Malaysia
University Malaya Medical Centre Recruiting
Kuala Lumpur, Federal Territory, Malaysia, 59100
Principal Investigator: Sanjiv Mahadeva, MRCP, MD         
Sponsors and Collaborators
University of Malaya
Zhejiang Provincial Hospital of TCM
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: Sanjiv Mahadeva, MRCP, MD University Malaya

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Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT02134405    
Other Study ID Numbers: 037-OTC-1203i
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016
Keywords provided by University of Malaya:
functional dyspepsia
symptoms
proton pump inhibitor
gastritis
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Esomeprazole
Rebamipide
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Physiological Effects of Drugs