Adults 24 to 64, any sex, with GERD. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in GERD SymptomsPrimary· Time 0 (baseline) to 8 weeks
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 adjuste
Group
Value
95% CI
Standard Visit
0.6
± 1.6
Expanded Visit
-1.7
± 3.7
Relationship of Physiologic Concordance in Skin Conductance Between Patient and Physician With Patients' GERD Symptom ChangeSecondary· Time 0 (baseline) to 8 weeks.
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 v
Group
Value
95% CI
Standard Visit
0.02
± 0.47
Expanded Visit
-2.2
± 4.8
Adverse events — posted to ClinicalTrials.gov
Time frame: 8 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is designed to assess the physiologic and behavioral mechanisms associated with enhanced medication effects in adult patients with functional GERD-related symptoms.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of California, Davis
Last refreshed: 28 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04292470.