Physiology of GERD and Treatment Response

March 24, 2023 updated by: University of California, Davis
This study is designed to assess the physiologic and behavioral mechanisms associated with enhanced medication effects in adult patients with functional GERD-related symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 measured in the patient-provider dyads and the visits video recorded. Subjects will receive a two-month supply of amitriptyline (10 mg/day), along with instructions for taking it. Subjects will complete a daily GERD symptom diary during the first and eighth weeks of the study. At the end of the 8-week observation period, subjects will complete follow-up measures of GERD symptom severity and quality of life.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amitriptyline
Amitriptyline 10 mg daily
Drug: Amitriptyline
Amitriptyline tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in GERD Symptoms
Time Frame: Time 0 (baseline) to 8 weeks
Change in the average daily GERD symptom severity score over a 7-day period from baseline to the last week of the study in the expanded vs. standard group. GERD symptom severity is based on the sum of scores assessing the severity of daytime heartburn, nighttime heartburn, and acid reflux each on a 0-4 point scale (none, mild, moderate, severe, very severe; higher scores signify worse symptoms). Possible score range = 0 - 12. Change score calculated as average score at 8 weeks minus average score at baseline. For statistical testing, we used a general linear model of post-GERD symptoms adjusted for baseline GERD symptoms and randomization assignment.
Time 0 (baseline) to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship of Physiologic Concordance in Skin Conductance Between Patient and Physician With Patients' GERD Symptom Change
Time Frame: Time 0 (baseline) to 8 weeks.
Concordance in skin conductance response (SCR) between patient and physician was calculated using an established approach to create a single index value for the visit (baseline). Average slopes of the SCR were calculated in moving 5 second windows, offset by 1 second. Pearson correlations between time-locked patient and physician SCR slopes were calculated over successive 15 second windows. A single session index was calculated from the ratio of the sum of the positive correlations across the entire visit divided by the sum of the absolute value of the negative correlations across the entire visit. To reduce skew, the natural logarithm of the index was calculated. An index value of zero reflects equal positive and negative correlations, a value greater than zero reflects more concordance in SCR than not, while a value less than zero reflects less than 50% concordance. In the statistical analysis, we included change in GERD symptoms from baseline to 8 weeks.
Time 0 (baseline) to 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Michelle Dossett, MD, PhD, MPH, University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2020

Primary Completion (Actual)

November 4, 2021

Study Completion (Actual)

November 4, 2021

Study Registration Dates

First Submitted

February 27, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1485210
  • K23AT009218 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Will need to request written permission and obtain a data sharing agreement and permission from the IRB to receive individual level participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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