NCT00164775|CompletedPhase 3
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Sponsor study identifier
interventional
107
1 country
1
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2010
Actual (reported)Study Completion
August 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2010
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 9, 2005
Actual (reported)September 14, 2005
Actual (reported)August 2010
Actual (reported)August 2010
Actual (reported)Overall satisfactory relief (Global Symptom Assessment) at 12 weeks
It is defined as a response of "Yes" to the question: "Do you experience overall satisfactory relief of dyspeptic symptom with the current treatment?" by global symptom assessment.
12 weeks
Individual dyspeptic symptom scores
12 weeks
Days of sleep disturbance
12 weeks
Mood assessment
12 weeks
Imipramine 25mg nocte for first 2 weeks then Imipramine 50 mg nocte for 10 weeks
Placebo 1 tablet for first 2 weeks then Placebo 2 tablets for 10 weeks
25mg nocte for first 2 weeks then 50 mg nocte for 10 weeks
One tab nocte for first 2 weeks then 2 tabs for 10 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Prince of Wales Hospital
Hong Kong, Hong Kong
Cheong PK, Ford AC, Cheung CKY, Ching JYL, Chan Y, Sung JJY, Chan FKL, Wu JCY. Low-dose imipramine for refractory functional dyspepsia: a randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2018 Dec;3(12):837-844. doi: 10.1016/S2468-1253(18)30303-0. Epub 2018 Oct 22.
Justin CY Wu, MD
Chinese University of Hong Kong
107 participants (actual enrollment reported by the registry).
First Submitted
September 9, 2005
First Posted
September 14, 2005
Study Start
June 2005
Date type not reportedThis date has not been verified as actual or estimated.
Study to Learn More About the Stomach and Intestine Complaints of Children Aged From 3 to 14 Years
Contact the study team to confirm eligibility.
Primary Completion
August 2010
Actual (reported)Study Completion
August 2010
Actual (reported)Last Updated
September 16, 2016
Record last verified: 2016-09
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Source: ClinicalTrials.gov.
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