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

Mahidol University83 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gastroesophageal Reflux Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

improvement of GERD score

Time frame: 6 months

Secondary Outcomes

improve quality of life