The aim of this study is to establish a dose-related effect of a selective 5-HT4 receptor agonist compared to placebo on residual symptoms (regurgitation with or without heartburn) in subjects with GERD who have persistent symptoms while on PPI therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
480
0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI
0.5 mg tablet t.i.d. taken in addition to a PPI
2.0 mg tablet t.i.d. taken in addition to a PPI
Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8
Time frame: Baseline and over weeks 5-8
Change From Baseline in Heartburn-Free Days Over Weeks 5-8
Time frame: Baseline and over weeks 5-8
Change From Baseline in the Persistent Reflux Integrated Symptom Measurement (PRISM) Liquid and Food Domain Scores Over Weeks 5-8
PRISM is a 21 item patient-reported outcome instrument with 4 domains. Items are scored using various scales. Total score ranges from 0-100. Higher scores indicate more severe or frequent symptoms.
Time frame: Baseline and over weeks 5-8
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-002358
Area under the plasma concentration versus time curve can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time frame: Over 8 hours post-dose (week 2 or later)
Steady State Maximum Plasma Concentration (Cmax) of SSP-002358
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.
Time frame: Over 8 hours post-dose (week 2 or later)
Time to Maximum Plasma Concentration (Tmax) of SSP-002358
Time frame: Over 8 hours post-dose (week 2 or later)
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Placebo t.i.d. taken in addition to a PPI
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...and 78 more locations