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OpenTrials
Completed

NCT Number: NCT01753128

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

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

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Institue; Siriraj Hospital

Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imipramine

Drug

Primary outcomes

  1. improvement of GERD score

    Time frame: 6 months

Secondary outcomes

  1. improve quality of life

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Efficacy of Imipramine for Treatment of Patients With Esophageal

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 20, 2012
Registry last updated
Aug 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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