Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)
A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate Efficacy of a Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD) With Persistent Regurgitation With or Without Heartburn
2 other identifiers
interventional
480
6 countries
88
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2012
Shorter than P25 for phase_2
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedStudy Start
First participant enrolled
February 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2013
CompletedResults Posted
Study results publicly available
April 15, 2014
CompletedJune 9, 2021
May 1, 2021
1.2 years
November 14, 2011
March 4, 2014
May 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8
Baseline and over weeks 5-8
Secondary Outcomes (5)
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
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-002358
Over 8 hours post-dose (week 2 or later)
Steady State Maximum Plasma Concentration (Cmax) of SSP-002358
Over 8 hours post-dose (week 2 or later)
Time to Maximum Plasma Concentration (Tmax) of SSP-002358
Over 8 hours post-dose (week 2 or later)
Study Arms (4)
SSP-002358 (0.1 mg) + Proton Pump Inhibitor (PPI)
ACTIVE COMPARATORSSP-002358 (0.5 mg) + PPI
ACTIVE COMPARATORSSP-002358 (2.0 mg) + PPI
ACTIVE COMPARATORPlacebo + PPI
PLACEBO COMPARATORInterventions
0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI
0.5 mg tablet t.i.d. taken in addition to a PPI
2.0 mg tablet t.i.d. taken in addition to a PPI
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (88)
HOPE Research Institute
Phoenix, Arizona, 85050, United States
Genova Clinical Research
Tucson, Arizona, 85704, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205, United States
Preferred Research Partners, Inc
Little Rock, Arkansas, 72211, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117, United States
Anaheim Clinical Trials
Anaheim, California, 92801-2417, United States
Southern California Research Institute Medical Group Inc
Los Angeles, California, 90045, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Clinicos
Colorado Springs, Colorado, 80904, United States
Connecticut Gastroenterology Institute
Bristol, Connecticut, 06010, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Medical Research Unlimited, LLC
Aventura, Florida, 33180, United States
Consultants for Clinical Research of South Florida
Boynton Beach, Florida, 33426, United States
PAB Clinical Research
Brandon, Florida, 33511, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
S & W Clinical Research
Fort Lauderdale, Florida, 33306, United States
Medical Research Unlimited, LLC
Hialeah, Florida, 33012, United States
Jupiter Research
Jupiter, Florida, 33458, United States
Pines Clinical Research, Inc.
Pembroke Pines, Florida, 33028, United States
Radiant Research
Pinellas Park, Florida, 33781, United States
Accord Clinical Research, LLC
Port Orange, Florida, 32129, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Gastrointestinal Specialists of GA, PC
Marietta, Georgia, 30060, United States
Digestive Research Associates
Newnan, Georgia, 30263, United States
Rockford Gastroenterology Associates, Ltd
Rockford, Illinois, 61107, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67203, United States
Research Integrity
Owensboro, Kentucky, 42303, United States
Clinical Trials Management
Metairie, Louisiana, 70006, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71103, United States
Meritus Medical Center
Hagerstown, Maryland, 21742, United States
Beacon Clinical Research
Brockton, Massachusetts, 02301, United States
Center for Digestive and Liver Diseases
Mexico, Missouri, 65265, United States
Clinical Research Group of Montana
Bozeman, Montana, 59718, United States
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104, United States
New Jersey Physicians, LLC
Clifton, New Jersey, 07012, United States
UNC Hospitals
Chapel Hill, North Carolina, 27599, United States
Carolinas Research Associates
Davidson, North Carolina, 28036, United States
Cumberland Research Associates
Fayetteville, North Carolina, 28314, United States
Vital Research, Inc.
Greensboro, North Carolina, 27408, United States
Carolinas Research Associates
Harrisburg, North Carolina, 28075, United States
Peters Medical Research
High Point, North Carolina, 27262, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Oklahoma Foundation for Digestive Research Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Family Medical Associates
Levittown, Pennsylvania, 19056, United States
Guthrie Clinic, Ltd.
Sayre, Pennsylvania, 18840, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Meridian Clinical Research
Dakota Dunes, South Dakota, 57049, United States
Clinsearch, LLC
Chattanooga, Tennessee, 37421, United States
Radiant Research Dallas-North
Dallas, Texas, 75231, United States
GI Consultants, P.A.
Houston, Texas, 77034, United States
Pasadena Gastroenterology Assoc, dba Digestive Health Center
Pasadena, Texas, 77505, United States
Office Based Practitioner
San Antonio, Texas, 78229, United States
Advanced Research Institute
Clinton, Utah, 84015, United States
Advanced Research Institute
Logan, Utah, 84341, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
Advanced Research Institute
Sandy City, Utah, 84094, United States
New River Valley Research Institute
Christiansburg, Virginia, 24073, United States
Blue Ridge Medical Center
Lynchburg, Virginia, 24502, United States
Ramstad Medical Associates
Suffolk, Virginia, 23435, United States
Aurora Wilkinson Medical Clinic
Summit, Wisconsin, 53066, United States
Hepato-Gastroenterology HK s.r.o.
Hradec Králové, 50012, Czechia
Nemocnice Valasske Mezirici a.s.
Valašské Meziříčí, 75742, Czechia
Praxis Dr. Andreas Schwittay-Facharzt fuer Innere Medizin
Böhlen, 4564, Germany
Zentrum fur Innere Medizin, Klinikum Garmisch Partenkirchen
Garmisch-Partenkirchen, 82467, Germany
Haus der Gesundheit
Ludwigshafen, 67067, Germany
Praxis für Gastroenterologie und fachärztliche Innere Medizin
Ludwigshafen, 67067, Germany
Medizinische Fakultät der Otto-von-Guericke Universität
Magdeburg, 39120, Germany
Gemeinschaftspraxis Dres. Brandt
Potsdam, 14482, Germany
Gemeinschaftspraxis Dres Josef und Wilma Großkopf
Wallerfing, 94574, Germany
Daugavpils Regional Hospital
Daugavpils, 5417, Latvia
Pauls Stradins Clinical University Hospital
Riga, 1002, Latvia
Digestive Disease Centre "Gastro"
Riga, 1006, Latvia
Vidzemes Hospital
Valmiera, 4201, Latvia
NZOZ Specjalistyczne Centrum Gastrologii Gastromed
Bialystok, 15-351, Poland
Centrum Medyczne im Swietego Lukasza Sp. z o.o.
Częstochowa, 42-202, Poland
NZOZ ''Salvia''
Katowice, 40-772, Poland
Centrum Medyczne Szpital sw. Rodziny Sp. z o.o.
Lodz, 90-302, Poland
Gastromed Sp. K. NZOZ
Lublin, 20-607, Poland
Endoskopia Sp. z o.o.
Sopot, 81-756, Poland
NZOZ Vivamed
Warsaw, 03-580, Poland
Lexmedica
Wroclaw, 53-025, Poland
Aktywne Centrum Zdrowia NZOZ ZAWIDAWIE Sp. z o.o.
Wroclaw, 54-239, Poland
Brasov County Hospital
Brasov, 500326, Romania
Centrul Medical Galenus
Târgu Mureş, 540098, Romania
Cabinet Particular Policlinic Algomed SRL
Timișoara, 300002, Romania
Policlinica "Dr. Citu" SRL
Timișoara, 300594, Romania
Related Publications (1)
Shaheen NJ, Adler J, Dedrie S, Johnson D, Malfertheiner P, Miner P, Meulemans A, Poole L, Tack J, Thielemans L, Troy S, Vakil N, Zerbib F, Ruth M. Randomised clinical trial: the 5-HT4 agonist revexepride in patients with gastro-oesophageal reflux disease who have persistent symptoms despite PPI therapy. Aliment Pharmacol Ther. 2015 Apr;41(7):649-61. doi: 10.1111/apt.13115. Epub 2015 Feb 19.
PMID: 25693609DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2011
First Posted
November 17, 2011
Study Start
February 27, 2012
Primary Completion
May 14, 2013
Study Completion
May 14, 2013
Last Updated
June 9, 2021
Results First Posted
April 15, 2014
Record last verified: 2021-05