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The Efficacy of Imipramine in Treatment of Refractory Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT00164775
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
Justin Che-Yuen Wu, Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date September 16, 2016
Study Start Date  ICMJE June 2005
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2016)
Overall satisfactory relief (Global Symptom Assessment) at 12 weeks [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
  • Primary Outcome:
  • The overall satisfactory relief of dyspepsia at 12 weeks.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2016)
  • Individual dyspeptic symptom scores [ Time Frame: 12 weeks ]
    8-item dyspepsia symptom score questionnaire assessing epigastric pain, epigastric burning, postprandial fullness, early satiety, belching, bloating, nausea, and vomiting on a scale of 0-3 over the last 7 days
  • Days of sleep disturbance [ Time Frame: 12 weeks ]
    Effect on sleep will be assessed by asking patients if they had insomnia on ≥1 day per week
  • Mood assessment [ Time Frame: 12 weeks ]
    Effect on mood will be assessed using the hospital anxiety and depression scale (HADS)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Imipramine in Treatment of Refractory Functional Dyspepsia
Official Title  ICMJE The Efficacy of Imipramine in Treatment of Functional Dyspepsia: A Double Blind Randomized Placebo Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Functional Gastrointestinal Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Imipramine
    Imipramine 25mg nocte for first 2 weeks then Imipramine 50 mg nocte for 10 weeks
    Intervention: Drug: Imipramine
  • Placebo Comparator: Placebo
    Placebo 1 tablet for first 2 weeks then Placebo 2 tablets for 10 weeks
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2016)
107
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
368
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients fulfill the diagnostic criteria of functional dyspepsia as defined by Rome II criteria
  • Age > 18 years old
  • Failure of treatment response to PPI, H2 receptor antagonist fo 8 weeks and 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries China
 
Administrative Information
NCT Number  ICMJE NCT00164775
Other Study ID Numbers  ICMJE DA Study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Justin Che-Yuen Wu, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Justin CY Wu, MD Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP