- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01643083
Rifaximin for Functional Dyspepsia
November 30, 2015 updated by: LEUNG Wai Keung, The University of Hong Kong
Use of Rifaximin in Patients With Functional Dyspepsia: A Randomized Controlled Trial
Functional dyspepsia is a very common medical condition, which occurs in up to 30% of people in the community.
However, results of current pharmacological treatment on functional dyspepsia are unsatisfactory.
Rifaximin is a minimally absorbed antibiotic that has been used in treatment of non-constipated irritable bowel syndrome (IBS).
In particular, bloating and abdominal pain was improved by rifaximin treatment in this group of IBS patients.
Whilst there is considerable overlap in symptoms of functional dyspepsia and IBS, the investigators test whether rifaximin is also effective in curing post-prandial distress symptoms related to dyspepsia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to test the effects of rifaximin, a minimally absorbed antibiotics, on symptoms of patients with functional dyspepsia.
Study Type
Interventional
Enrollment (Actual)
95
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Hong Kong, China
- Queen Mary Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Non-ulcer dyspeptic patients who fulfill post-prandial distress syndrome according to the Rome III Criteria
- Active dyspeptic symptom
- Normal upper endoscopy
- Urea Breath Test -ve or Rapid urease test -ve
- Not typical gastroesophageal reflux or biliary colic symptoms, but presence of infrequent acid reflux is allowed
Exclusion Criteria:
- No active dyspeptic symptom
- Allergic to rifaximin
- Recent antibiotics use in the past 8 wk
- Recent PPI or H2RA in past 4 wk
- On anti-coagulants, anti-convulsant or oral contraceptives
- On NSAIDs, aspirin or Clopidogrel
- Pregnancy or breast feeding
- Previous gastric surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Placebo for 2 week
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ACTIVE_COMPARATOR: Rifaximin
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Rifaximin 400mg tid for 2 wk
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adequate relief of dyspeptic symptoms at end of treatment
Time Frame: end of treatment (week 2)
|
global symptom improvement
|
end of treatment (week 2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Individual dyspeptic symptom scores
Time Frame: week 2, 4 and 8
|
Hong Kong Dyspeptic Index
|
week 2, 4 and 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (ACTUAL)
May 1, 2015
Study Completion (ACTUAL)
May 1, 2015
Study Registration Dates
First Submitted
July 15, 2012
First Submitted That Met QC Criteria
July 16, 2012
First Posted (ESTIMATE)
July 17, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
December 2, 2015
Last Update Submitted That Met QC Criteria
November 30, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HKU_RD1
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 Functional Dyspepsia
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King Chulalongkorn Memorial HospitalRecruiting
-
Wuhan Central HospitalNot yet recruiting
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Dong-A ST Co., Ltd.Not yet recruitingFunctional DyspepsiaKorea, Republic of
-
Universitaire Ziekenhuizen KU LeuvenRecruiting
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Universitaire Ziekenhuizen KU LeuvenRecruiting
-
Zeria PharmaceuticalRecruitingFunctional DyspepsiaJapan
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Hong Kong Baptist UniversityXiyuan Hospital of China Academy of Chinese Medical SciencesRecruitingFunctional DyspepsiaHong Kong
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Seoul National University HospitalCompletedFunctional DyspepsiaKorea, Republic of
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Wonju Severance Christian HospitalCompletedFunctional DyspepsiaKorea, Republic of
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Daewoong Pharmaceutical Co. LTD.CompletedFunctional DyspepsiaKorea, Republic of
Clinical Trials on Rifaximin
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Alfasigma S.p.A.TerminatedDiverticulitisFrance, Germany, Italy, Netherlands, Spain, United Kingdom
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SandozTerminatedTravelers' DiarrheaMexico
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National University Hospital, SingaporeNational University, SingaporeCompletedIrritable Bowel Syndrome With DiarrheaSingapore
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Shanghai Changzheng HospitalUnknown
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Sun Yat-sen UniversityRecruitingHepatic Encephalopathy | Hepatitis B | HBV | Effect of Drug | Liver Failure, Acute on Chronic | RifaximinChina
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Bausch Health Americas, Inc.Active, not recruitingHepatic EncephalopathyUnited States, Australia, Canada, Puerto Rico