NCT00164775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

5.2 years

First QC Date

September 9, 2005

Last Update Submit

September 14, 2016

Conditions

Functional Gastrointestinal Disorder

Keywords

Functional dyspepsia, refractory, antidepressant

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Individual dyspeptic symptom scores

    12 weeks

  • Days of sleep disturbance

    12 weeks

  • Mood assessment

    12 weeks

Study Arms (2)

Imipramine

ACTIVE COMPARATOR

Imipramine 25mg nocte for first 2 weeks then Imipramine 50 mg nocte for 10 weeks

Drug: Imipramine

Placebo

PLACEBO COMPARATOR

Placebo 1 tablet for first 2 weeks then Placebo 2 tablets for 10 weeks

Drug: Placebo

Interventions

ImipramineDRUG

25mg nocte for first 2 weeks then 50 mg nocte for 10 weeks

Imipramine
PlaceboDRUG

One tab nocte for first 2 weeks then 2 tabs for 10 weeks

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

    PMID: 30361080DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Imipramine

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Justin CY Wu, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

June 1, 2005

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

September 16, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)