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The Efficacy of Imipramine in Treatment of Functional Dyspepsia: A Double Blind Randomized Placebo Controlled Trial
This study is currently recruiting participants.
Verified by Chinese University of Hong Kong, November 2006
First Received: September 9, 2005   Last Updated: March 21, 2008   History of Changes
Sponsor: Chinese University of Hong Kong
Information provided by: Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00164775
  Purpose

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.


Condition Intervention Phase
Dyspepsia
Drug: Imipramine
Drug: placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Primary Outcome: Overall satisfactory relief (GSA) at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Individual dyspepsia symptom scores Days of sleep disturbance SODA score Response in different subtypes of dyspepsia [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 368
Study Start Date: June 2005
Arms Assigned Interventions
1: Experimental
Imipramine
Drug: Imipramine
50 mg nocte for 12 weeks
2: Placebo Comparator
Placebo
Drug: placebo

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 pathophysiology of functional dyspepsia is not fully understood and the correlation of those proposed mechanisms with the clinical characteristics and treatment response is poor. Owing to the poor understanding on the mechanism, treatment of functional dyspepsia has been far from satisfactory. There are numerous modalities of medical treatment that has been reported to be effective but the results are conflicting. Large and well-controlled studies in functional dyspepsia have shown that proton pump inhibitor had a therapeutic gain of about 10%-15% better than placebo in patients with functional dyspepsia. However, this positive effect was restricted to patients with reflux-like dyspepsia, a subgroup that actually is no longer considered to belong to functional dyspepsia. Prokinetic agent is another class of drug that has been widely used in functional dyspepsia. Although recent reviews suggest that prokinetics are more effective than placebo, most trials were flawed with significant heterogeneity among studies. Tricyclic antidepressant (TCA) is another important class of drug that is commonly used in various functional gastrointestinal disorders (FGID) and chronic pain disorders. The effectiveness of TCA in FGID has been supported by a meta-analysis, which reported that improvement in global GI symptoms against placebo was highly significant. The mechanism of TCA in treatment of FGID is poorly understood but the therapeutic effect is evident even in low dose, suggesting that it is independent of its anti-depressive action. To date, clinical trial of TCA in treatment of FD with sufficient sample size and well-defined clinical endpoint is still lacking. So the objective of this study is to evaluate the efficacy of imipramine, a tricyclic antidepressant, in treatment of functional dyspepsia.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients fulfill the diagnostic criteria of functional dyspepsia as defined by Rome II criteria.
  • Age >18
  • Failure of treatment response to PPI, H2 receptor antagonist, 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00164775

Contacts
Contact: Justin C Wu, MD 85226323024 justinwu@cuhk.edu.hk
Contact: Jessica P Cheong, Dip 85226323855 jessicacheong@cuhk.edu.hk

Locations
China
Endoscopy Center, Prince of Wales Hospital Recruiting
Hong Kong, China
Contact: Justin C Wu, MD     85226323024     justinwu@cuhk.edu.hk    
Contact: Jessica P Cheong, Dip     85226323855     jessicacheong@cuhk.edu.hk    
Principal Investigator: Justin C Wu, MD            
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Justin C Wu, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: CUHK ( Dr. Justin CY Wu )
Study ID Numbers: DA Study
Study First Received: September 9, 2005
Last Updated: March 21, 2008
ClinicalTrials.gov Identifier: NCT00164775     History of Changes
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Dyspepsia
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Signs and Symptoms
Imipramine
Therapeutic Uses
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 27, 2009