Efficacy of Imipramine for Treatment of Patients With Esophageal Hypersensitivity/ Functional Heartburn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01753128
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : August 18, 2014
Information provided by (Responsible Party):
Mahidol University

Brief Summary:

Esophageal hypersensitivity/Functional heartburn are common among non-erosive reflux disease (NERD) patients who do not response to proton pump inhibitors. Whether tricyclic antidepressant improves NERD patient's symptoms remains unknown

Aim of this randomized controlled trial study is to determine the efficacy of imipramine, which could increase esophageal pain thresholds in healthy volunteers, in comparison with placebo for treatment patients with esophageal hypersensitivity or functional heartburn evaluated by improvement of specific-symptom score and quality of life

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: imipramine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Imipramine for Treatment of Patients With Esophageal
Study Start Date : December 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD Heartburn

Arm Intervention/treatment
Active Comparator: imipramine Drug: imipramine

Primary Outcome Measures :
  1. improvement of GERD score [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. improve quality of life [ Time Frame: 6 months ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • patient with typical reflux symptoms (heartburn and/or regurgitation) more than 3 times per week in at least last 3 months
  • Age more than 18 years
  • Upper GI endoscopy showed no esophageal mucosal breaks
  • MII-pH monitoring was not showed abnormal both acid and non-acid reflux
  • symptoms was not improved after received standard dose proton pump inhibitor for at least 1 month

Exclusion Criteria:

  • history of thoracic, esophagus, or stomach surgery
  • severe esophageal motility disorder eg. Achalasia, scleroderma, autonomic/peripheral neuropathy/myopathy
  • patient who was indicated to receive proton pump inhibitor
  • pregnant women
  • patient who was allergy to imipramine
  • patient who received tricyclic antidepressant or SSRI with in 3 month of enrollment

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 identifier (NCT number): NCT01753128

Medical Institue; Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Principal Investigator: Julajak Limsrivilai, MD Mahidol University

Responsible Party: Mahidol University Identifier: NCT01753128     History of Changes
Other Study ID Numbers: 334/2553 (EC3)
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
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