Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164775
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2005-09-09
Brief Title:
The Efficacy of Imipramine in Treatment of Refractory Functional Dyspepsia
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
The Efficacy of Imipramine in Treatment of Functional Dyspepsia A Double Blind Randomized Placebo Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None