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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

Tracking Information
First Submitted Date  ICMJE February 27, 2020
First Posted Date  ICMJE March 3, 2020
Last Update Posted Date November 13, 2020
Actual Study Start Date  ICMJE November 5, 2020
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2020)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physiology of GERD and Treatment Response
Official Title  ICMJE Physiology of GERD and Treatment Response
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE GERD
Intervention  ICMJE Drug: Amitriptyline
Amitriptyline tablet
Study Arms  ICMJE Experimental: Amitriptyline
Amitriptyline 10 mg daily
Intervention: Drug: Amitriptyline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 27, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Michelle Dossett, MD, PhD, MPH 916-734-5367 mdossett@ucdavis.edu
Contact: Megan Kohn 916-734-0525 mekohn@ucdavis.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04292470
Other Study ID Numbers  ICMJE 1485210
K23AT009218 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Michelle Dossett, MD, PhD, MPH University of California, Davis
PRS Account University of California, Davis
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP