Conditions: Gastroesophageal Reflux Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 480
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: SSP-002358 (0.1 mg) + PPI intervention 2: SSP-002358 (0.5 mg) + PPI intervention 3: SSP-002358 (2.0 mg) + PPI intervention 4: Placebo + PPI
Intervention descriptions: intervention 1: 0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI intervention 2: 0.5 mg tablet t.i.d. taken in addition to a PPI intervention 3: 2.0 mg tablet t.i.d. taken in addition to a PPI intervention 4: Placebo t.i.d. taken in addition to a PPI

Protocol document: