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Physiology of GERD and Treatment Response

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ClinicalTrials.gov Identifier: NCT04292470
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of California, Davis

Study Description
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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.

Condition or disease Intervention/treatment Phase
GERD Drug: Amitriptyline Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physiology of GERD and Treatment Response
Actual Study Start Date : November 5, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Amitriptyline
Amitriptyline 10 mg daily
 Drug: Amitriptyline
Amitriptyline tablet


Outcome Measures
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Primary Outcome Measures :
  1. Change in GERD symptoms [ Time Frame: 8 weeks (study visit 1 to study visit 2) ]
    Average daily GERD symptom severity during the last 7 days of the study compared to average daily GERD symptom severity at baseline using daily study diary entries. GERD symptom severity for each day 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.


Secondary Outcome Measures :
  1. Correlation of physiologic concordance with GERD symptom change [ Time Frame: 8 weeks (study visit 1 to study visit 2) ]
    Ratio of the sum of positive correlations over the sum of negative correlations in GSR (or HRV) across patient-provider encounters and for responders vs. non-responders (those with a 50% or greater improvement in their GERD symptom severity).


Eligibility Criteria
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Ages Eligible for Study:   24 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04292470


Contacts
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Contact: Michelle Dossett, MD, PhD, MPH 916-734-5367 mdossett@ucdavis.edu
Contact: Megan Kohn 916-734-0525 mekohn@ucdavis.edu

Locations
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United States, California
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Megan Kohn    916-734-0525    mekohn@ucdavis.edu   
Principal Investigator: Michelle Dossett, MD, PhD, MPH         
Sponsors and Collaborators
University of California, Davis
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Michelle Dossett, MD, PhD, MPH University of California, Davis
More Information
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04292470    
Other Study ID Numbers: 1485210
K23AT009218 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Amitriptyline
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants