Status:
COMPLETED
The Efficacy of Imipramine in Treatment of Refractory Functional Dyspepsia
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Functional Gastrointestinal Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of this study is evaluate the efficacy of Imipramine, a tricyclic antidepressant, in treatment of functional dyspepsia. This is a double blind randomised placebo controlled trial in which cons...
Detailed Description
Functional dyspepsia is a heterogeneous disorder that consists of a variety of upper gastrointestinal symptoms such as postprandial fullness, early satiety, pain, bloating, belching, or nausea. The pa...
Eligibility Criteria
Inclusion
- Patients fulfill the diagnostic criteria of functional dyspepsia as defined by Rome II criteria
- Age \> 18 years old
- Failure of treatment response to PPI, H2 receptor antagonist fo 8 weeks and domperidone for 4 weeks
Exclusion
- Organic pathology detected by endoscopy
- GERD or IBS as dominant compliant
- Presence of any alarm symptom: anemia, recurrent vomiting, weight loss
- Concomitant Helicobacter pylori infection
- Concomitant use of neuroleptic or antidepressant, NSAID
- Previous gastrointestinal surgery
- Cardiac arrhythmia, untreated glaucoma or benign prostate hypertrophy
- Pregnancy
- Known hypersensitivity or contraindication for tricyclic antidepressant
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00164775
Start Date
June 1 2005
End Date
August 1 2010
Last Update
September 16 2016
Active Locations (1)
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1
Prince of Wales Hospital
Hong Kong, Hong Kong