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

NCT ID: NCT01753128

Last Updated: 2014-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-09-30

Brief Summary

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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

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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imipramine

Group Type ACTIVE_COMPARATOR

imipramine

Intervention Type DRUG

Interventions

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imipramine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julajak Limsrivilai, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Medical Institue; Siriraj Hospital

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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334/2553 (EC3)

Identifier Type: -

Identifier Source: org_study_id

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