Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)
- Conditions
- Gastroesophageal Reflux Disease
- Interventions
- Drug: SSP-002358 (0.5 mg) + PPIDrug: SSP-002358 (2.0 mg) + PPIDrug: Placebo + PPIDrug: SSP-002358 (0.1 mg) + PPI
- Registration Number
- NCT01472939
- Lead Sponsor
- Shire
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SSP-002358 (0.5 mg) + PPI SSP-002358 (0.5 mg) + PPI - SSP-002358 (2.0 mg) + PPI SSP-002358 (2.0 mg) + PPI - Placebo + PPI Placebo + PPI - SSP-002358 (0.1 mg) + Proton Pump Inhibitor (PPI) SSP-002358 (0.1 mg) + PPI -
- Primary Outcome Measures
Name Time Method Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8 Baseline and over weeks 5-8
- Secondary Outcome Measures
Name Time Method Change From Baseline in Heartburn-Free Days Over Weeks 5-8 Baseline and over weeks 5-8 Change From Baseline in the Persistent Reflux Integrated Symptom Measurement (PRISM) Liquid and Food Domain Scores Over Weeks 5-8 Baseline and over weeks 5-8 PRISM is a 21 item patient-reported outcome instrument with 4 domains. Items are scored using various scales. Total score ranges from 0-100. Higher scores indicate more severe or frequent symptoms.
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-002358 Over 8 hours post-dose (week 2 or later) Area under the plasma concentration versus time curve can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Steady State Maximum Plasma Concentration (Cmax) of SSP-002358 Over 8 hours post-dose (week 2 or later) Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.
Time to Maximum Plasma Concentration (Tmax) of SSP-002358 Over 8 hours post-dose (week 2 or later)
Trial Locations
- Locations (82)
S & W Clinical Research
🇺🇸Fort Lauderdale, Florida, United States
Research Integrity
🇺🇸Owensboro, Kentucky, United States
Guthrie Clinic, Ltd.
🇺🇸Sayre, Pennsylvania, United States
Southern California Research Institute Medical Group Inc
🇺🇸Los Angeles, California, United States
Gastromed Sp. K. NZOZ
🇵🇱Lublin, Poland
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
GI Consultants, P.A.
🇺🇸Houston, Texas, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
New River Valley Research Institute
🇺🇸Christiansburg, Virginia, United States
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
Oklahoma Foundation for Digestive Research Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Office Based Practitioner
🇺🇸San Antonio, Texas, United States
Clinical Research Group of Montana
🇺🇸Bozeman, Montana, United States
Preferred Research Partners, Inc
🇺🇸Little Rock, Arkansas, United States
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States
Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States
Arkansas Gastroenterology
🇺🇸North Little Rock, Arkansas, United States
Clinicos
🇺🇸Colorado Springs, Colorado, United States
Stamford Therapeutics Consortium
🇺🇸Stamford, Connecticut, United States
Medical Research Unlimited, LLC
🇺🇸Hialeah, Florida, United States
Consultants for Clinical Research of South Florida
🇺🇸Boynton Beach, Florida, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
Pines Clinical Research, Inc.
🇺🇸Pembroke Pines, Florida, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
Jupiter Research
🇺🇸Jupiter, Florida, United States
Radiant Research
🇺🇸Pinellas Park, Florida, United States
Meridien Research
🇺🇸Saint 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
Clinical Trials Management
🇺🇸Metairie, Louisiana, United States
Meridian Clinical Research
🇺🇸Dakota Dunes, South Dakota, United States
New Jersey Physicians, LLC
🇺🇸Clifton, New Jersey, United States
Meritus Medical Center
🇺🇸Hagerstown, Maryland, United States
Beacon Clinical Research
🇺🇸Brockton, Massachusetts, United States
Carolinas Research Associates
🇺🇸Harrisburg, North Carolina, United States
Peters Medical Research
🇺🇸High Point, North Carolina, United States
Radiant Research Dallas-North
🇺🇸Dallas, Texas, United States
Advanced Research Institute
🇺🇸Sandy, Utah, United States
Blue Ridge Medical Center
🇺🇸Lynchburg, Virginia, United States
Ramstad Medical Associates
🇺🇸Suffolk, Virginia, United States
Aurora Wilkinson Medical Clinic
🇺🇸Summit, Wisconsin, United States
Nemocnice Valasske Mezirici a.s.
🇨🇿Valasske Mezirici, Czechia
Zentrum fur Innere Medizin, Klinikum Garmisch Partenkirchen
🇩🇪Garmisch Partenkirchen, Germany
Hepato-Gastroenterology HK s.r.o.
🇨🇿Hradec Kralove, Czechia
Haus der Gesundheit
🇩🇪Ludwigshafen, Germany
Praxis Dr. Andreas Schwittay-Facharzt fuer Innere Medizin
🇩🇪Bohlen, Germany
Praxis für Gastroenterologie und fachärztliche Innere Medizin
🇩🇪Ludwigshafen, Germany
Medizinische Fakultät der Otto-von-Guericke Universität
🇩🇪Magdeburg, Germany
Gemeinschaftspraxis Dres Josef und Wilma Großkopf
🇩🇪Wallerfing, Germany
Daugavpils Regional Hospital
🇱🇻Daugavpils, Latvia
Gemeinschaftspraxis Dres. Brandt
🇩🇪Potsdam, Germany
Vidzemes Hospital
🇱🇻Valmiera, Latvia
NZOZ Specjalistyczne Centrum Gastrologii Gastromed
🇵🇱Bialystok, Poland
NZOZ Vivamed
🇵🇱Warszawa, Poland
NZOZ ''Salvia''
🇵🇱Katowice, Poland
Centrul Medical Galenus
🇷🇴Targu-Mures, Romania
Brasov County Hospital
🇷🇴Brasov, Romania
Cabinet Particular Policlinic Algomed SRL
🇷🇴Timisoara, Romania
Policlinica "Dr. Citu" SRL
🇷🇴Timisoara, Romania
Genova Clinical Research
🇺🇸Tucson, Arizona, United States
Professional Research Network of Kansas, LLC
🇺🇸Wichita, Kansas, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Connecticut Gastroenterology Institute
🇺🇸Bristol, Connecticut, United States
Cumberland Research Associates
🇺🇸Fayetteville, North Carolina, United States
Pasadena Gastroenterology Assoc, dba Digestive Health Center
🇺🇸Pasadena, Texas, United States
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
Accord Clinical Research, LLC
🇺🇸Port Orange, Florida, United States
Family Medical Associates
🇺🇸Levittown, Pennsylvania, United States
Vital Research, Inc.
🇺🇸Greensboro, North Carolina, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Clinsearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Lexmedica
🇵🇱Wroclaw, Poland
Digestive Disease Centre "Gastro"
🇱🇻Riga, Latvia
Centrum Medyczne im Swietego Lukasza Sp. z o.o.
🇵🇱Czestochowa, Poland
Centrum Medyczne Szpital sw. Rodziny Sp. z o.o.
🇵🇱Lodz, Poland
Endoskopia Sp. z o.o.
🇵🇱Sopot, Poland
Aktywne Centrum Zdrowia NZOZ ZAWIDAWIE Sp. z o.o.
🇵🇱Wroclaw, Poland
UNC Hospitals
🇺🇸Chapel Hill, North Carolina, United States
Center for Digestive and Liver Diseases
🇺🇸Mexico, Missouri, United States