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NCT01472939 · ClinicalTrials.gov registry record · Phase 2
Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)
A Phase 2 study of Gastroesophageal Reflux Disease, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 480
- Enrollment target
- 20
- Study locations
NCT01472939: Completed Phase 2 study of Gastroesophageal Reflux Disease, sponsored by Shire.
NCT01472939 is a Phase 2 study of Gastroesophageal Reflux Disease that has completed, run by Shire. The registered enrollment target is 480 participants, above the 337-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (42% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01472939, a Phase 2 study of Gastroesophageal Reflux Disease, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 480 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG SSP-002358 (0.1 mg) + PPI
- DRUG SSP-002358 (0.5 mg) + PPI
- DRUG SSP-002358 (2.0 mg) + PPI
- DRUG Placebo + PPI
Study Locations (20)
Florida
- Medical Research Unlimited, LLC - Aventura
- Consultants for Clinical Research of South Florida - Boynton Beach
- PAB Clinical Research - Brandon
- Avail Clinical Research, LLC - DeLand
- S & W Clinical Research - Fort Lauderdale
- Medical Research Unlimited, LLC - Hialeah
- Jupiter Research - Jupiter
- Pines Clinical Research, Inc. - Pembroke Pines
- Radiant Research - Pinellas Park
Arkansas
- Lynn Institute of the Ozarks - Little Rock
- Preferred Research Partners, Inc - Little Rock
- Arkansas Gastroenterology - North Little Rock
California
- Anaheim Clinical Trials - Anaheim
- Southern California Research Institute Medical Group Inc - Los Angeles
- Medical Center for Clinical Research - San Diego
Arizona
- HOPE Research Institute - Phoenix
- Genova Clinical Research - Tucson
Connecticut
- Connecticut Gastroenterology Institute - Bristol
- Stamford Therapeutics Consortium - Stamford
Colorado
- Clinicos - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 480 participants |
| Start Date | 2012-02-27 |
| Est. Completion | 2013-05-14 |
| Phase | Phase 2 |
What the finished NCT01472939 record still lists
NCT01472939 is an interventional study that assigns participants to a tested intervention. The registered 480 participants enrollment target is mid-sized for trials with a published cap, above the 337-participant average among 25 other Gastroesophageal Reflux Disease trials with a reported enrollment target (42% higher).
The record links to 1 condition, with Gastroesophageal Reflux Disease appearing as the primary indexed condition, and to 4 interventions - of which SSP-002358 (0.1 mg) + PPI is the first listed.
NCT01472939 names 20 study sites across 6 states, led by Florida, Arkansas, California.
Frequently Asked Questions
What is clinical trial NCT01472939 about?
NCT01472939 is a clinical study titled "Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)". 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.
What is the current status of trial NCT01472939?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 480 participants. The study started on 2012-02-27. Estimated completion is 2013-05-14.
What conditions does trial NCT01472939 study?
This clinical trial studies the following conditions: Gastroesophageal Reflux Disease.
What interventions are being tested in trial NCT01472939?
The interventions under investigation include: SSP-002358 (0.1 mg) + PPI (DRUG), SSP-002358 (0.5 mg) + PPI (DRUG), SSP-002358 (2.0 mg) + PPI (DRUG), Placebo + PPI (DRUG).
Who is sponsoring clinical trial NCT01472939?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01472939 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01472939's enrollment target sits among peer trials
480 5th of 25 higher than 21 of 25 other Gastroesophageal Reflux Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroesophageal Reflux Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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