N/A
N=7
Physiology of GERD and Treatment Response
GERD
Bottom Line
View on ClinicalTrials.gov: NCT04292470 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Change in GERD Symptoms — 0.6; -1.7 units on a scale — p=0.41
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Amitriptyline (Drug)
- Age
- Adult · 24+ yrs
- Sex
- All
- Sponsor
- University of California, Davis
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in GERD Symptoms |
0.6; -1.7 | 0.41 |
| SECONDARY Relationship of Physiologic Concordance in Skin Conductance Between Patient and Physician With Patients' GERD Symptom Change |
0.02; -2.2 | 0.09 |
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.
Eligibility Criteria
Inclusion Criteria
- Adults ages 24-64 years old
- Functional heartburn (defined as 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
Data sourced from ClinicalTrials.gov (NCT04292470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.