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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472939
• Other study ID #: SPD557-206
• Secondary ID: 2011-004388-62
• Status: Completed
• Phase: Phase 2
• Start date: February 27, 2012
• Est. completion date: May 14, 2013

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: May 14, 2013
• Est. primary completion date: May 14, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Written Informed Consent Form signed voluntarily before the first study-related activity.

2. Aged between 18 and 70 years, inclusive.

3. Subjects with a history of the cardinal symptoms of GERD (both heartburn and regurgitation) prior to PPI therapy.

4. Subjects with symptoms of GERD for at least 6 months prior to the Screening Visit.

5. Subjects who have persistent symptoms of regurgitation for 3 or more days over the past week with or without heartburn while on PPI.

6. Subjects have at least some improvement to the symptom of heartburn while on PPI therapy.

7. 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)

Exclusion Criteria:

1. Subjects who show no response to heartburn while on PPI therapy.

2. Subjects with dyspepsia symptoms that are more predominant than their GERD symptoms (heartburn and/or regurgitation).

3. Subjects with prior endoscopic anti-reflux procedure or major GI surgery or subjects with major GI disorders.

4. Presence of severe and clinically uncontrolled cardiovascular, liver, lung or neurologic disease, cancer or AIDS.

5. Alarm symptoms suggestive of malignancies or organic disease.

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• SSP-002358 (0.1 mg) + PPI
0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI
• SSP-002358 (0.5 mg) + PPI
0.5 mg tablet t.i.d. taken in addition to a PPI
• SSP-002358 (2.0 mg) + PPI
2.0 mg tablet t.i.d. taken in addition to a PPI
• Placebo + PPI
Placebo t.i.d. taken in addition to a PPI

Locations

Country	Name	City	State
Czechia	Hepato-Gastroenterology HK s.r.o.	Hradec Kralove
Czechia	Nemocnice Valasske Mezirici a.s.	Valasske Mezirici
Germany	Praxis Dr. Andreas Schwittay-Facharzt fuer Innere Medizin	Bohlen
Germany	Zentrum fur Innere Medizin, Klinikum Garmisch Partenkirchen	Garmisch Partenkirchen
Germany	Haus der Gesundheit	Ludwigshafen
Germany	Praxis für Gastroenterologie und fachärztliche Innere Medizin	Ludwigshafen
Germany	Medizinische Fakultät der Otto-von-Guericke Universität	Magdeburg
Germany	Gemeinschaftspraxis Dres. Brandt	Potsdam
Germany	Gemeinschaftspraxis Dres Josef und Wilma Großkopf	Wallerfing
Latvia	Daugavpils Regional Hospital	Daugavpils
Latvia	Digestive Disease Centre "Gastro"	Riga
Latvia	Pauls Stradins Clinical University Hospital	Riga
Latvia	Vidzemes Hospital	Valmiera
Poland	NZOZ Specjalistyczne Centrum Gastrologii Gastromed	Bialystok
Poland	Centrum Medyczne im Swietego Lukasza Sp. z o.o.	Czestochowa
Poland	NZOZ ''Salvia''	Katowice
Poland	Centrum Medyczne Szpital sw. Rodziny Sp. z o.o.	Lodz
Poland	Gastromed Sp. K. NZOZ	Lublin
Poland	Endoskopia Sp. z o.o.	Sopot
Poland	NZOZ Vivamed	Warszawa
Poland	Aktywne Centrum Zdrowia NZOZ ZAWIDAWIE Sp. z o.o.	Wroclaw
Poland	Lexmedica	Wroclaw
Romania	Brasov County Hospital	Brasov
Romania	Centrul Medical Galenus	Targu-Mures
Romania	Cabinet Particular Policlinic Algomed SRL	Timisoara
Romania	Policlinica "Dr. Citu" SRL	Timisoara
United States	Anaheim Clinical Trials	Anaheim	California
United States	Medical Research Unlimited, LLC	Aventura	Florida
United States	Consultants for Clinical Research of South Florida	Boynton Beach	Florida
United States	Clinical Research Group of Montana	Bozeman	Montana
United States	PAB Clinical Research	Brandon	Florida
United States	Connecticut Gastroenterology Institute	Bristol	Connecticut
United States	Beacon Clinical Research	Brockton	Massachusetts
United States	UNC Hospitals	Chapel Hill	North Carolina
United States	Clinsearch, LLC	Chattanooga	Tennessee
United States	New River Valley Research Institute	Christiansburg	Virginia
United States	New Jersey Physicians, LLC	Clifton	New Jersey
United States	Advanced Research Institute	Clinton	Utah
United States	Clinicos	Colorado Springs	Colorado
United States	Meridian Clinical Research	Dakota Dunes	South Dakota
United States	Radiant Research Dallas-North	Dallas	Texas
United States	Carolinas Research Associates	Davidson	North Carolina
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Cumberland Research Associates	Fayetteville	North Carolina
United States	S & W Clinical Research	Fort Lauderdale	Florida
United States	Prestige Clinical Research	Franklin	Ohio
United States	Vital Research, Inc.	Greensboro	North Carolina
United States	Meritus Medical Center	Hagerstown	Maryland
United States	Carolinas Research Associates	Harrisburg	North Carolina
United States	Medical Research Unlimited, LLC	Hialeah	Florida
United States	Peters Medical Research	High Point	North Carolina
United States	GI Consultants, P.A.	Houston	Texas
United States	Jupiter Research	Jupiter	Florida
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Family Medical Associates	Levittown	Pennsylvania
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	Preferred Research Partners, Inc	Little Rock	Arkansas
United States	Advanced Research Institute	Logan	Utah
United States	Southern California Research Institute Medical Group Inc	Los Angeles	California
United States	Blue Ridge Medical Center	Lynchburg	Virginia
United States	Gastrointestinal Specialists of GA, PC	Marietta	Georgia
United States	Clinical Trials Management	Metairie	Louisiana
United States	Center for Digestive and Liver Diseases	Mexico	Missouri
United States	Digestive Research Associates	Newnan	Georgia
United States	Arkansas Gastroenterology	North Little Rock	Arkansas
United States	Advanced Research Institute	Ogden	Utah
United States	Oklahoma Foundation for Digestive Research Sciences Center	Oklahoma City	Oklahoma
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Research Integrity	Owensboro	Kentucky
United States	Pasadena Gastroenterology Assoc, dba Digestive Health Center	Pasadena	Texas
United States	Pines Clinical Research, Inc.	Pembroke Pines	Florida
United States	HOPE Research Institute	Phoenix	Arizona
United States	Radiant Research	Pinellas Park	Florida
United States	Accord Clinical Research, LLC	Port Orange	Florida
United States	Wake Research Associates	Raleigh	North Carolina
United States	Rockford Gastroenterology Associates, Ltd	Rockford	Illinois
United States	Meridien Research	Saint Petersburg	Florida
United States	Office Based Practitioner	San Antonio	Texas
United States	Medical Center for Clinical Research	San Diego	California
United States	Advanced Research Institute	Sandy	Utah
United States	Guthrie Clinic, Ltd.	Sayre	Pennsylvania
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	Ramstad Medical Associates	Suffolk	Virginia
United States	Aurora Wilkinson Medical Clinic	Summit	Wisconsin
United States	Genova Clinical Research	Tucson	Arizona
United States	Omega Medical Research	Warwick	Rhode Island
United States	Professional Research Network of Kansas, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Countries where clinical trial is conducted

United States,  Czechia,  Germany,  Latvia,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8		Baseline and over weeks 5-8
Secondary	Change From Baseline in Heartburn-Free Days Over Weeks 5-8		Baseline and over weeks 5-8
Secondary	Change From Baseline in the Persistent Reflux Integrated Symptom Measurement (PRISM) Liquid and Food Domain Scores 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.	Baseline and over weeks 5-8
Secondary	Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-002358	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.	Over 8 hours post-dose (week 2 or later)
Secondary	Steady State Maximum Plasma Concentration (Cmax) of SSP-002358	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.	Over 8 hours post-dose (week 2 or later)
Secondary	Time to Maximum Plasma Concentration (Tmax) of SSP-002358		Over 8 hours post-dose (week 2 or later)