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| Sponsored by: |
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 |
| 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 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Justin C Wu, MD | 85226323024 | justinwu@cuhk.edu.hk |
| Contact: Jessica P Cheong, Dip | 85226323855 | jessicacheong@cuhk.edu.hk |
| 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 | |
| Principal Investigator: | Justin C Wu, MD | Chinese University of Hong Kong |
More Information
| 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 |
|
Signs and Symptoms Neurotransmitter Agents Imipramine Adrenergic Agents Signs and Symptoms, Digestive |
Psychotropic Drugs Dyspepsia Antidepressive Agents Antidepressive Agents, Tricyclic |
|
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 |