Back to resultsEfficacy of Imipramine for Treatment of Patients With Esophageal Hypersensitivity/ Functional Heartburn
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
imipramine
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease
Eligibility 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
Sites / Locations
- Medical Institue; Siriraj Hospital
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
imipramine
Arm Description
Outcomes
Primary Outcome Measures
improvement of GERD score
Secondary Outcome Measures
improve quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01753128
Brief Title
Efficacy of Imipramine for Treatment of Patients With Esophageal Hypersensitivity/ Functional Heartburn
Official Title
Efficacy of Imipramine for Treatment of Patients With Esophageal
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
imipramine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
imipramine
Primary Outcome Measure Information:
Title
improvement of GERD score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
improve quality of life
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julajak Limsrivilai, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Institue; Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Imipramine for Treatment of Patients With Esophageal Hypersensitivity/ Functional Heartburn
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