Overview

Physiology of GERD and Treatment Response

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of California, Davis
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Treatments:
Amitriptyline
Amitriptyline, perphenazine drug combination
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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