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The Efficacy of Imipramine in Treatment of Refractory Functional Dyspepsia

NCT00164775 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2016-09-16

No results posted yet for this study

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.

Conditions

  • Functional Gastrointestinal Disorder

Interventions

DRUG

Imipramine

25mg nocte for first 2 weeks then 50 mg nocte for 10 weeks

DRUG

Placebo

One tab nocte for first 2 weeks then 2 tabs for 10 weeks

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Justin CY Wu, MD · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00164775 on ClinicalTrials.gov