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COMPLETED Phase 2

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

NCT01472939 · View on ClinicalTrials.gov ↗

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

56 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01472939

The ClinicalTrials.gov registry entry for NCT01472939 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 56 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01472939 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, Arkansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01472939?

This trial is sponsored by Shire, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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