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Physiology of GERD and Treatment Response

Primary Purpose

GERD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amitriptyline
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for GERD

Eligibility Criteria

24 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California Davis Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amitriptyline

Arm Description

Amitriptyline 10 mg daily

Outcomes

Primary Outcome Measures

Change in GERD Symptoms
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.

Secondary Outcome Measures

Relationship of Physiologic Concordance in Skin Conductance Between Patient and Physician With Patients' GERD Symptom Change
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.

Full Information

First Posted
February 27, 2020
Last Updated
March 24, 2023
Sponsor
University of California, Davis
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04292470
Brief Title
Physiology of GERD and Treatment Response
Official Title
Physiology of GERD and Treatment Response
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
November 4, 2021 (Actual)
Study Completion Date
November 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amitriptyline
Arm Type
Experimental
Arm Description
Amitriptyline 10 mg daily
Intervention Type
Drug
Intervention Name(s)
Amitriptyline
Intervention Description
Amitriptyline tablet
Primary Outcome Measure Information:
Title
Change in GERD Symptoms
Description
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 Frame
Time 0 (baseline) to 8 weeks
Secondary Outcome Measure Information:
Title
Relationship of Physiologic Concordance in Skin Conductance Between Patient and Physician With Patients' GERD Symptom Change
Description
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 Frame
Time 0 (baseline) to 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Dossett, MD, PhD, MPH
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
12094846
Citation
Miner P Jr, Orr W, Filippone J, Jokubaitis L, Sloan S. Rabeprazole in nonerosive gastroesophageal reflux disease: a randomized placebo-controlled trial. Am J Gastroenterol. 2002 Jun;97(6):1332-9. doi: 10.1111/j.1572-0241.2002.05769.x.
Results Reference
background
PubMed Identifier
17299296
Citation
Marci CD, Ham J, Moran E, Orr SP. Physiologic correlates of perceived therapist empathy and social-emotional process during psychotherapy. J Nerv Ment Dis. 2007 Feb;195(2):103-11. doi: 10.1097/01.nmd.0000253731.71025.fc.
Results Reference
background

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Physiology of GERD and Treatment Response

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