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

May 14, 2021 updated by: Shire

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

480

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Hradec Kralove, Czechia, 50012
        • Hepato-Gastroenterology HK s.r.o.
      • Valasske Mezirici, Czechia, 75742
        • Nemocnice Valasske Mezirici a.s.
  • Germany
      • Bohlen, Germany, 4564
        • Praxis Dr. Andreas Schwittay-Facharzt fuer Innere Medizin
      • Garmisch Partenkirchen, Germany, 82467
        • Zentrum fur Innere Medizin, Klinikum Garmisch Partenkirchen
      • Ludwigshafen, Germany, 67067
        • Haus der Gesundheit
      • Ludwigshafen, Germany, 67067
        • Praxis für Gastroenterologie und fachärztliche Innere Medizin
      • Magdeburg, Germany, 39120
        • Medizinische Fakultät der Otto-von-Guericke Universität
      • Potsdam, Germany, 14482
        • Gemeinschaftspraxis Dres. Brandt
      • Wallerfing, Germany, 94574
        • Gemeinschaftspraxis Dres Josef und Wilma Großkopf
  • Latvia
      • Daugavpils, Latvia, 5417
        • Daugavpils Regional Hospital
      • Riga, Latvia, 1002
        • Pauls Stradins Clinical University Hospital
      • Riga, Latvia, 1006
        • Digestive Disease Centre "Gastro"
      • Valmiera, Latvia, 4201
        • Vidzemes Hospital
  • Poland
      • Bialystok, Poland, 15-351
        • NZOZ Specjalistyczne Centrum Gastrologii GASTROMED
      • Czestochowa, Poland, 42-202
        • Centrum Medyczne im Swietego Lukasza Sp. z o.o.
      • Katowice, Poland, 40-772
        • NZOZ ''Salvia''
      • Lodz, Poland, 90-302
        • Centrum Medyczne Szpital sw. Rodziny Sp. z o.o.
      • Lublin, Poland, 20-607
        • Gastromed Sp. K. NZOZ
      • Sopot, Poland, 81-756
        • Endoskopia Sp. z o.o.
      • Warszawa, Poland, 03-580
        • NZOZ Vivamed
      • Wroclaw, Poland, 53-025
        • LexMedica
      • Wroclaw, Poland, 54-239
        • Aktywne Centrum Zdrowia NZOZ ZAWIDAWIE Sp. z o.o.
  • Romania
      • Brasov, Romania, 500326
        • Brasov County Hospital
      • Targu-Mures, Romania, 540098
        • Centrul Medical Galenus
      • Timisoara, Romania, 300002
        • Cabinet Particular Policlinic Algomed SRL
      • Timisoara, Romania, 300594
        • Policlinica "Dr. Citu" SRL
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • HOPE Research Institute
      • Tucson, Arizona, United States, 85704
        • Genova Clinical Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Lynn Institute of the Ozarks
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partners, Inc
      • North Little Rock, Arkansas, United States, 72117
        • Arkansas Gastroenterology
    • California
      • Anaheim, California, United States, 92801-2417
        • Anaheim Clinical Trials
      • Los Angeles, California, United States, 90045
        • Southern California Research Institute Medical Group Inc
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
        • Clinicos
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Connecticut Gastroenterology Institute
      • Stamford, Connecticut, United States, 06905
        • Stamford Therapeutics Consortium
    • Florida
      • Aventura, Florida, United States, 33180
        • Medical Research Unlimited, Llc
      • Boynton Beach, Florida, United States, 33426
        • Consultants for Clinical Research of South Florida
      • Brandon, Florida, United States, 33511
        • PAB Clinical Research
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research, LLC
      • Fort Lauderdale, Florida, United States, 33306
        • S & W Clinical Research
      • Hialeah, Florida, United States, 33012
        • Medical Research Unlimited, Llc
      • Jupiter, Florida, United States, 33458
        • Jupiter Research
      • Pembroke Pines, Florida, United States, 33028
        • Pines Clinical Research, Inc.
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research
      • Port Orange, Florida, United States, 32129
        • Accord Clinical Research, LLC
      • Saint Petersburg, Florida, United States, 33709
        • Meridien Research
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of GA, PC
      • Newnan, Georgia, United States, 30263
        • Digestive Research Associates
    • Illinois
      • Rockford, Illinois, United States, 61107
        • Rockford Gastroenterology Associates, Ltd
    • Kansas
      • Wichita, Kansas, United States, 67203
        • Professional Research Network of Kansas, LLC
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Research Integrity
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Clinical Trials Management
      • Shreveport, Louisiana, United States, 71103
        • Louisiana Research Center, LLC
    • Maryland
      • Hagerstown, Maryland, United States, 21742
        • Meritus Medical Center
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Beacon Clinical Research
    • Missouri
      • Mexico, Missouri, United States, 65265
        • Center for Digestive and Liver Diseases
    • Montana
      • Bozeman, Montana, United States, 59718
        • Clinical Research Group of Montana
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Meridian Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • Clinical Research Center of Nevada
    • New Jersey
      • Clifton, New Jersey, United States, 07012
        • New Jersey Physicians, LLC
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Hospitals
      • Davidson, North Carolina, United States, 28036
        • Carolinas Research Associates
      • Fayetteville, North Carolina, United States, 28314
        • Cumberland Research Associates
      • Greensboro, North Carolina, United States, 27408
        • Vital Research, Inc.
      • Harrisburg, North Carolina, United States, 28075
        • Carolinas Research Associates
      • High Point, North Carolina, United States, 27262
        • Peters Medical Research
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • Ohio
      • Franklin, Ohio, United States, 45005
        • Prestige Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Foundation for Digestive Research Sciences Center
    • Pennsylvania
      • Levittown, Pennsylvania, United States, 19056
        • Family Medical Associates
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Clinic, Ltd.
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Meridian Clinical Research
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • ClinSearch, LLC
    • Texas
      • Dallas, Texas, United States, 75231
        • Radiant Research Dallas-North
      • Houston, Texas, United States, 77034
        • GI Consultants, P.A.
      • Pasadena, Texas, United States, 77505
        • Pasadena Gastroenterology Assoc, dba Digestive Health Center
      • San Antonio, Texas, United States, 78229
        • Office Based Practitioner
    • Utah
      • Clinton, Utah, United States, 84015
        • Advanced Research Institute
      • Logan, Utah, United States, 84341
        • Advanced Research Institute
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute
      • Sandy, Utah, United States, 84094
        • Advanced Research Institute
    • Virginia
      • Christiansburg, Virginia, United States, 24073
        • New River Valley Research Institute
      • Lynchburg, Virginia, United States, 24502
        • Blue Ridge Medical Center
      • Suffolk, Virginia, United States, 23435
        • Ramstad Medical Associates
    • Wisconsin
      • Summit, Wisconsin, United States, 53066
        • Aurora Wilkinson Medical Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SSP-002358 (0.1 mg) + Proton Pump Inhibitor (PPI)
Drug: SSP-002358 (0.1 mg) + PPI
0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI
Other Names:
  • SPD557
Active Comparator: SSP-002358 (0.5 mg) + PPI
Drug: SSP-002358 (0.5 mg) + PPI
0.5 mg tablet t.i.d. taken in addition to a PPI
Active Comparator: SSP-002358 (2.0 mg) + PPI
Drug: SSP-002358 (2.0 mg) + PPI
2.0 mg tablet t.i.d. taken in addition to a PPI
Placebo Comparator: Placebo + PPI
Drug: Placebo + PPI
Placebo t.i.d. taken in addition to a PPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8
Time Frame: Baseline and over weeks 5-8
Baseline and over weeks 5-8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Heartburn-Free Days Over Weeks 5-8
Time Frame: Baseline and 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
Time Frame: 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.
Baseline and over weeks 5-8
Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-002358
Time Frame: 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.
Over 8 hours post-dose (week 2 or later)
Steady State Maximum Plasma Concentration (Cmax) of SSP-002358
Time Frame: 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.
Over 8 hours post-dose (week 2 or later)
Time to Maximum Plasma Concentration (Tmax) of SSP-002358
Time Frame: Over 8 hours post-dose (week 2 or later)
Over 8 hours post-dose (week 2 or later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2012

Primary Completion (Actual)

May 14, 2013

Study Completion (Actual)

May 14, 2013

Study Registration Dates

First Submitted

November 14, 2011

First Submitted That Met QC Criteria

November 16, 2011

First Posted (Estimate)

November 17, 2011

Study Record Updates

Last Update Posted (Actual)

June 9, 2021

Last Update Submitted That Met QC Criteria

May 14, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD557-206
  • 2011-004388-62 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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