Physiology of GERD and Treatment Response

NCT04292470 | Completed Results DMC

• 2 other identifiers: 1485210K23AT009218
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

• 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.

  Time 0 (baseline) to 8 weeks

Secondary Outcomes (1)

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

  Time 0 (baseline) to 8 weeks.

Study Arms (1)

Amitriptyline

EXPERIMENTAL

Amitriptyline 10 mg daily

Drug: Amitriptyline

Interventions

Amitriptyline DRUG

Amitriptyline tablet

Amitriptyline

Eligibility Criteria

• Age: 24 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (2)

• 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.

  PMID: 12094846 BACKGROUND

• 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.

  PMID: 17299296 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Amitriptyline

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Michelle Dossett
• Organization: University of California Davis

mdossett@ucdavis.edu

916-734-5367

Study Officials

• Michelle Dossett, MD, PhD, MPH

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 3, 2020
• Study Start: November 5, 2020
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: March 28, 2023
• Results First Posted: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)