- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02134405
Rebamipide in Combination With Esomeprazole in the Management of Asian Patients With Functional Dyspepsia
Rebamipide in Combination With Esomeprazole in the Management of Asian Patients With Functional Dyspepsia: a Multi-national, Randomised, Double-blind, Placebo-controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objective: 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 Objective: 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 ii. To assess the cost-effectiveness of Rebamipide in combination with Esomeprazole compared to Esomeprazole alone after 8, 12 weeks of treatment iii. To assess the safety of Rebamipide in combination with Esomeprazole in adults with functional dyspepsia after 8 weeks of treatment.
Trial Design Multi-national, randomised, double-blind, placebo-controlled study
Treatment Group:
- Study Group: Rebamipide + Esomeprazole
Control Group: Rebamipide placebo + Esomeprazole Investigational Product (IP): Rebamipide 100 mg tablet Rebamipide placebo tablet Esomeprazole 20 mg tablet Dosage regimen: Administration route: PO Rebamipide 100 mg t.i.d Rebamipide placebo t.i.d Esomeprazole 20 mg o.d Target Population Male or female subjects aged from 18 years to less than 80 years with a diagnosed of Functional Dyspepsia (FD) Primary Endpoint: Change in Leeds Dyspepsia Questionnaire (LDQ) total score from baseline to 8 weeks of treatment Secondary Endpoints: 1. The change in Health-Related Quality of Life (EQ-5D) from baseline to 8 weeks of treatment 2. The cost effectiveness based on cost per QALY gained between the study group compared to the control group at 8, 12 weeks 3. The change in Leeds Dyspepsia Questionnaire (LDQ) total score and Health-Related Quality of Life (EQ-5D) from baseline to 12 weeks 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 (more than 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 Duration of treatment: 8 weeks Number of subjects: Ninety-three patients per each group with 90% power at the 0.05 significance level were used. Considering 10% drop-out rate, total of 208 patients (104 patients per each group) will be enrolled in the study.
Total: 208 Study Group: 104 Control Group: 104 Anticipated Timelines: Duration of trial: 18 months Start of recruitment: March 2014 End of recruitment: August 2015 Last subject out: Oct 2015
Statistical Methodology:
Primary Endpoint Change in Leeds Dyspepsia Questionnaire (LDQ) total score from baseline to 8 weeks of treatment
Secondary Endpoint
- The change in Health-Related Quality of Life (EQ-5D) from baseline to 8 weeks of treatment
- The cost effectiveness based on cost per QALY gained between the study groups compared to the control group at 8, 12 weeks
- The change in Leeds Dyspepsia Questionnaire (LDQ) total score and Health-Related Quality of Life (EQ-5D) from baseline to 12 weeks
Summary statistics of the endpoints will be provided. Mean change will be evaluated by two sample t-test or Wilcoxon's rank sum test according to the normal distribution of analyzed variable.
Safety Endpoint
- Adverse events The number of cases of AEs and the proportion of patients who experienced AEs will be summarized by descriptive statistics (frequency and proportion) for each study group.
- Laboratory Test and Vital Signs All laboratory values and vital signs will be compared within study group and between study groups.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Sanjiv Mahadeva, MRCP, MD
- Phone Number: 60122171743
- Email: sanjiv@ummc.edu.my
Study Locations
-
-
Federal Territory
-
Kuala Lumpur, Federal Territory, Malaysia, 59100
- Recruiting
- University Malaya Medical Centre
-
Principal Investigator:
- Sanjiv Mahadeva, MRCP, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rebamipide and Esomeprazole
Rebamipide tablets 100mg tid for 8 weeks Esomeprazole tablets 20mg od for 8 weeks
|
Rebamipide 100mg tid
Other Names:
Esomeprazole tablets 20mg o.d. for 8 weeks
Other Names:
|
Active Comparator: Rebamipide and placebo
Placebo drug with Rebamipide 100mg tid
|
Rebamipide 100mg tid
Other Names:
Sugar pill manufactured to mimic Esomeprazole
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks
|
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
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sanjiv Mahadeva, MRCP, MD, University Malaya
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 037-OTC-1203i
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dyspepsia
-
King Chulalongkorn Memorial HospitalRecruiting
-
Wuhan Central HospitalNot yet recruiting
-
Dong-A ST Co., Ltd.Not yet recruitingFunctional DyspepsiaKorea, Republic of
-
Universitaire Ziekenhuizen KU LeuvenRecruiting
-
Universitaire Ziekenhuizen KU LeuvenRecruiting
-
Zeria PharmaceuticalRecruitingFunctional DyspepsiaJapan
-
Hong Kong Baptist UniversityXiyuan Hospital of China Academy of Chinese Medical SciencesRecruitingFunctional DyspepsiaHong Kong
-
Seoul National University HospitalCompletedFunctional DyspepsiaKorea, Republic of
-
Wonju Severance Christian HospitalCompletedFunctional DyspepsiaKorea, Republic of
-
Daewoong Pharmaceutical Co. LTD.CompletedFunctional DyspepsiaKorea, Republic of
Clinical Trials on Rebamipide
-
Korea Otsuka Pharmaceutical Co., Ltd.CompletedHealthy VolunteersKorea, Republic of
-
Otsuka Pharmaceutical Co., Ltd.Completed
-
Korea Otsuka Pharmaceutical Co., Ltd.CompletedHealthy VolunteersKorea, Republic of
-
Dong-A Pharmaceutical Co., Ltd.UnknownAcute Gastritis | Chronic GastritisKorea, Republic of
-
Otsuka Pharmaceutical Co., Ltd.CompletedColitis, UlcerativeJapan
-
Otsuka Pharmaceutical Co., Ltd.Completed
-
Kubota Vision Inc.Otsuka Pharmaceutical Co., Ltd.Completed
-
Korea Otsuka Pharmaceutical Co., Ltd.RecruitingAcute Gastritis | Chronic GastritisKorea, Republic of
-
Samjin Pharmaceutical Co., Ltd.Completed
-
Otsuka Pakistan LimitedCompletedGastric UlcerPakistan