Status:
COMPLETED
Physiology of GERD and Treatment Response
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
GERD
Eligibility:
All Genders
24-64 years
Phase:
NA
Brief Summary
This study is designed to assess the physiologic and behavioral mechanisms associated with enhanced medication effects in adult patients with functional GERD-related symptoms.
Detailed Description
Subjects will complete questionnaires regarding their GERD-related symptoms and have a visit with a study clinician regarding their symptoms. Heart rate variability and galvanic skin response will be ...
Eligibility Criteria
Inclusion
- Adults ages 24-64 years old
- Functional heartburn (defined as \<4% of time with reflux on 24 hour pH manometry) symptoms 3 or more days per week with an average daily symptom severity of 3 or more on a 7-day baseline symptom diary
- English language proficiency
- Willingness to be videotaped and connected to physiologic monitoring devices during the visit
- Willingness to take amitriptyline daily for 8 weeks following study visit 1
Exclusion
- Diagnosis of Crohn's disease, systemic sclerosis, known active ulcer disease, gastric cancer, or untreated/active Barrett's esophagitis based on subject self-report and/or medical record review
- Heavy alcohol use (\> 6 drinks/week for women and \> 13 drinks/week for men) based on subject self-report
- Pregnant, attempting to become pregnant, or breast-feeding
- Dementia or significant memory difficulties as determined by the study team and medical record review
- Severe, unstable psychiatric disease based on subject self-report, study team determination, and/or medical record review
- Bipolar disorder, concurrent treatment with a SSRI or another antidepressant that interacts with tricyclic antidepressants
- Prolonged QTc or severe heart disease
- History of seizure disorder
- Severe liver impairment - e.g., cirrhosis, hepatocellular carcinoma, hepatitis
- Currently taking a tricyclic antidepressant, allergy to tricyclic antidepressants, or another medical contraindication to taking amitriptyline or related medications
- Greater than 15 doses of nonsteroidal anti-inflammatory drugs (NSAIDS) within the prior 30 days (aspirin ≤ 325 mg daily permitted) or ongoing NSAID use at a level deemed likely to interfere with the study
- Failure to complete the baseline symptom diary for at least 6 of 7 days
- Change in GERD treatment regimen within the last 2 weeks (subjects may use antacids, H2 receptor blockers, and/or proton pump inhibitors as long as they are symptomatic on a stable regimen)
- Allergy to adhesives
- Inability to provide informed consent
- In the opinion of the investigator, unable to comply with the study protocol or has a condition that would likely interfere with the study
Key Trial Info
Start Date :
November 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04292470
Start Date
November 5 2020
End Date
November 4 2021
Last Update
March 28 2023
Active Locations (1)
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1
University of California Davis Medical Center
Sacramento, California, United States, 95817