The Efficacy of Imipramine in Treatment of Refractory Functional Dyspepsia

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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 consecutive patients with diagnosis of functional dyspepsia will be studied. After exclusion of organic cause of dyspepsia by endoscopy, these patients will be randomly assigned to either imipramine or placebo. All the patients will enter an additional 4 weeks of drug withdrawal phase after the initial 12 weeks of study drug treatment. They will be evaluated for treatment response, which is defined as satisfactory relief of dyspeptic symptoms at the end of 12-week treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Imipramine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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