CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 480 enrolled
Drug / intervention
SSP-002358 (0.1 mg) + PPI +3 moredrug
Likely dose
SSP-002358 (0.1 mg) + PPIfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01472939
NCT01472939Phase 2Completed
CompareCT.gov

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

Shire·interventional·Posted Nov 17, 2011·Updated Jun 9, 2021

In Brief

A Phase 2 clinical trial evaluating SSP-002358 (0.1 mg) + PPI, SSP-002358 (0.5 mg) + PPI, and 2 other interventions for Gastroesophageal Reflux Disease. Completed, enrolled 480 participants across 88 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroesophageal Reflux Disease
CountriesCzechia, Germany, Latvia, Poland, Romania, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 17, 2011
Enrollment StartFeb 27, 2012
Primary CompletionMay 14, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.6 years ago

Interventions

SSP-002358 (0.1 mg) + PPIdrug

0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI

SSP-002358 (0.5 mg) + PPIdrug

0.5 mg tablet t.i.d. taken in addition to a PPI

SSP-002358 (2.0 mg) + PPIdrug

2.0 mg tablet t.i.d. taken in addition to a PPI

Placebo + PPIdrug

Placebo t.i.d. taken in addition to a PPI