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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Functional Gastrointestinal Disorder Drug: Imipramine Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Imipramine in Treatment of Functional Dyspepsia: A Double Blind Randomized Placebo Controlled Trial
Study Start Date : June 2005
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Imipramine
Imipramine 25mg nocte for first 2 weeks then Imipramine 50 mg nocte for 10 weeks
 Drug: Imipramine
25mg nocte for first 2 weeks then 50 mg nocte for 10 weeks
Placebo Comparator: Placebo
Placebo 1 tablet for first 2 weeks then Placebo 2 tablets for 10 weeks
 Drug: Placebo
One tab nocte for first 2 weeks then 2 tabs for 10 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Mood assessment [ Time Frame: 12 weeks ]
    Effect on mood will be assessed using the hospital anxiety and depression scale (HADS)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164775


Locations
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Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Justin CY Wu, MD Chinese University of Hong Kong
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Justin Che-Yuen Wu, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00164775    
Other Study ID Numbers: DA Study
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Justin Che-Yuen Wu, Chinese University of Hong Kong:
Functional dyspepsia, refractory, antidepressant
Additional relevant MeSH terms:
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Digestive System Diseases
Gastrointestinal Diseases
Dyspepsia
Signs and Symptoms, Digestive
Imipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
 Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs