NCT04292470

Physiology of GERD and Treatment Response

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 24 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• GERD

Interventions

Type	Name	Description
DRUG	Amitriptyline	Amitriptyline tablet

Timeline

• Start date: 2020-11-05
• Primary completion: 2021-11-04
• Completion: 2021-11-04
• First posted: 2020-03-03
• Last updated: 2023-03-28
• Results posted: 2023-03-28

Locations

1 site across 1 country: United States