Efficacy of Imipramine for Treatment of Patients With Esophageal Hypersensitivity/ Functional Heartburn
NCT ID: NCT01753128
Last Updated: 2014-08-18
Study Results
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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COMPLETED
PHASE3
83 participants
INTERVENTIONAL
2012-12-31
2013-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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imipramine
imipramine
Interventions
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imipramine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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334/2553 (EC3)
Identifier Type: -
Identifier Source: org_study_id
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