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

This study is currently recruiting participants.
Verified August 2010 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01753128
First received: December 17, 2012
Last updated: December 19, 2012
Last verified: August 2010
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Imipramine for Treatment of Patients With Esophageal

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • improvement of GERD score [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • improve quality of life [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: imipramine Drug: imipramine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753128

Contacts
Contact: Julajak Limsrivilai, MD 66814968895 alimsrivilai@gmail.com

Locations
Thailand
Medical Institue; Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Julajak Limsrivilai, MD     66814968895     alimsrivilai@gmail.com    
Principal Investigator: Julajak Limsrivilai, MD            
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Julajak Limsrivilai, MD Mahidol University
  More Information

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01753128     History of Changes
Other Study ID Numbers: 334/2553 (EC3)
Study First Received: December 17, 2012
Last Updated: December 19, 2012
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Gastroesophageal Reflux
Hypersensitivity
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Immune System Diseases
Imipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
 Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013