NCT01472939

Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)

A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate Efficacy of a Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD) With Persistent Regurgitation With or Without Heartburn

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	SSP-002358 (0.1 mg) + PPI	0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI
DRUG	SSP-002358 (0.5 mg) + PPI	0.5 mg tablet t.i.d. taken in addition to a PPI
DRUG	SSP-002358 (2.0 mg) + PPI	2.0 mg tablet t.i.d. taken in addition to a PPI
DRUG	Placebo + PPI	Placebo t.i.d. taken in addition to a PPI

Timeline

• Start date: 2012-02-27
• Primary completion: 2013-05-14
• Completion: 2013-05-14
• First posted: 2011-11-17
• Last updated: 2021-06-09
• Results posted: 2014-04-15

Locations

88 sites across 6 countries: United States, Czechia, Germany, Latvia, Poland, Romania