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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 is a Phase 2 study of Gastroesophageal Reflux Disease that has completed, run by Shire. The registered enrollment target is 480 participants, above the 328-participant average among 24 other Gastroesophageal Reflux Disease trials with a reported enrollment target (46% higher). The trial reports 20 study locations across 6 states.

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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.

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

FieldValue
Enrollment Target 480 participants
Start Date 2012-02-27
Est. Completion 2013-05-14
Phase Phase 2

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT01472939

The ClinicalTrials.gov registry entry for NCT01472939 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 328-participant average among 24 other Gastroesophageal Reflux Disease trials with a reported enrollment target (46% higher). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.