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

Completed · Phase 2 · Has a placebo group

Conditions studied: Gastroesophageal Reflux Disease

In brief

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.

Key facts

Study ID

NCT01472939

Run by

Shire

People needed

480

Starts

2012-02-27

Expected to finish

2013-05-14

Last updated by the study team

2021-06-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written Informed Consent Form signed voluntarily before the first study-related activity.
• Aged between 18 and 70 years, inclusive.
• Subjects with a history of the cardinal symptoms of GERD (both heartburn and regurgitation) prior to PPI therapy.
• Subjects with symptoms of GERD for at least 6 months prior to the Screening Visit.
• Subjects who have persistent symptoms of regurgitation for 3 or more days over the past week with or without heartburn while on PPI.
• Subjects have at least some improvement to the symptom of heartburn while on PPI therapy.
• Subjects on PPI therapy for at least 8 weeks prior to the Screening Visit of which the last 4 weeks are on a stable labeled dose for any GERD indication according to the country label, where a change of PPI therapy would not impact the symptoms (twice-daily dosing of PPI is not allowed in the last 4 weeks)

You may not qualify if…

• Subjects who show no response to heartburn while on PPI therapy.
• Subjects with dyspepsia symptoms that are more predominant than their GERD symptoms (heartburn and/or regurgitation).
• Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects with major GI disorders.
• Presence of severe and clinically uncontrolled cardiovascular, liver, lung or neurologic disease, cancer or AIDS.
• Alarm symptoms suggestive of malignancies or organic disease.

Where it is running

• Genova Clinical Research — Tucson, Arizona, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Preferred Research Partners, Inc — Little Rock, Arkansas, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• Anaheim Clinical Trials — Anaheim, California, United States
• Southern California Research Institute Medical Group Inc — Los Angeles, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Clinicos — Colorado Springs, Colorado, United States
• Connecticut Gastroenterology Institute — Bristol, Connecticut, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Medical Research Unlimited, LLC — Aventura, Florida, United States
• Consultants for Clinical Research of South Florida — Boynton Beach, Florida, United States
• PAB Clinical Research — Brandon, Florida, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• S & W Clinical Research — Fort Lauderdale, Florida, United States
• Medical Research Unlimited, LLC — Hialeah, Florida, United States
• Jupiter Research — Jupiter, Florida, United States
• Pines Clinical Research, Inc. — Pembroke Pines, Florida, United States
• Radiant Research — Pinellas Park, Florida, United States
• Accord Clinical Research, LLC — Port Orange, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States
• Gastrointestinal Specialists of GA, PC — Marietta, Georgia, United States
• Digestive Research Associates — Newnan, Georgia, United States
• Rockford Gastroenterology Associates, Ltd — Rockford, Illinois, United States
• HOPE Research Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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