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

Mahidol University

Status and phase

Completed

Phase 3

Conditions

Gastroesophageal Reflux Disease

Treatments

Drug: imipramine

Study type

Interventional

Funder types

Other

Identifiers

NCT01753128

334/2553 (EC3)

Details and patient eligibility

About

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

Enrollment

83 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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