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