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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01753128
First Posted: December 20, 2012
Last Update Posted: August 18, 2014
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.
Information provided by (Responsible Party):
Mahidol University
  Purpose

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 Intervention Phase
Gastroesophageal Reflux Disease Drug: imipramine Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Imipramine for Treatment of Patients With Esophageal

Resource links provided by NLM:


Further study details as provided by Mahidol University:

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

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

Enrollment: 83
Study Start Date: December 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: imipramine Drug: imipramine

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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): NCT01753128


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

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01753128     History of Changes
Other Study ID Numbers: 334/2553 (EC3)
First Submitted: December 17, 2012
First Posted: December 20, 2012
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
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