Efficacy of Imipramine for Treatment of Patients With Esophageal Hypersensitivity/ Functional Heartburn
1 other identifier
interventional
83
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2012
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 17, 2012
CompletedFirst Posted
Study publicly available on registry
December 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedAugust 18, 2014
August 1, 2014
9 months
December 17, 2012
August 15, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
improvement of GERD score
6 months
Secondary Outcomes (1)
improve quality of life
6 months
Study Arms (1)
imipramine
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Institue; Siriraj Hospital
Bangkok, Bangkok, 10700, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julajak Limsrivilai, MD
Mahidol University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2012
First Posted
December 20, 2012
Study Start
December 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
August 18, 2014
Record last verified: 2014-08