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

Phase 3

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: imipramine

• Registration Number: NCT01753128
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-20
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-15
• Last Update Posted: 2014-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
imipramine	imipramine	-

Primary Outcome Measures

Name	Time	Method
improvement of GERD score	6 months

Secondary Outcome Measures

Name	Time	Method
improve quality of life	6 months

Trial Locations

Locations (1)

Medical Institue; Siriraj Hospital; 🇹🇭 Bangkok, Thailand