Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Rifaximin for Functional Dyspepsia

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by The University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
LEUNG Wai Keung, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01643083
First received: July 15, 2012
Last updated: December 18, 2013
Last verified: December 2013

July 15, 2012
December 18, 2013
January 2013
September 2015   (final data collection date for primary outcome measure)
Adequate relief of dyspeptic symptoms at end of treatment [ Time Frame: end of treatment (week 2) ] [ Designated as safety issue: No ]
global symptom improvement
Same as current
Complete list of historical versions of study NCT01643083 on ClinicalTrials.gov Archive Site
Individual dyspeptic symptom scores [ Time Frame: week 2, 4 and 8 ] [ Designated as safety issue: No ]
Hong Kong Dyspeptic Index
Same as current
Not Provided
Not Provided
 
Rifaximin for Functional Dyspepsia
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.

The aim of this study is to test the effects of rifaximin, a minimally absorbed antibiotics, on symptoms of patients with functional dyspepsia.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Functional Dyspepsia
  • Drug: Rifaximin
    Rifaximin 400mg tid for 2 wk
    Other Name: Normix
  • Drug: Placebo
    Placebo for 2 week
  • Active Comparator: Rifaximin
    Intervention: Drug: Rifaximin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
December 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Wai Keung Leung, MD 85222553750 waikleung@hku.hk
China
 
NCT01643083
HKU_RD1
No
LEUNG Wai Keung, The University of Hong Kong
The University of Hong Kong
Not Provided
Principal Investigator: Wai Keung Leung, MD The University of Hong Kong
The University of Hong Kong
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP