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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Efficacy of Imipramine for Treatment of Patients With Esophageal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753128
• Other study ID #: 334/2553 (EC3)
• Status: Completed
• Phase: Phase 3
• First received: December 17, 2012
• Last updated: August 15, 2014
• Start date: December 2012
• Est. completion date: September 2013

Study information

• Verified date: August 2014
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• imipramine

Locations

Country	Name	City	State
Thailand	Medical Institue; Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of GERD score		6 months	Yes
Secondary	improve quality of life		6 months	Yes