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Gastroesophageal Reflux DiseasePhase 2NCT01472939

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

A Phase 2 study testing SSP-002358 (0.1 mg) + PPI, SSP-002358 (0.5 mg) + PPI and SSP-002358 (2.0 mg) + PPI in people with Gastroesophageal Reflux Disease, run by Shire at 88 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastroesophageal Reflux Disease
What is being tested?
SSP-002358 (0.1 mg) + PPI, SSP-002358 (0.5 mg) + PPI and SSP-002358 (2.0 mg) + PPI
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
480 participants
Where
88 sitesin 6 countries
Study dates
27 Feb 2012to 14 May 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

88 sites in 6 countries.

88 sites in 6 countries

United States62 sites

  • Anaheim Clinical Trials

    Anaheim, California, 92801-2417

  • Medical Research Unlimited, LLC

    Aventura, Florida, 33180

  • Consultants for Clinical Research of South Florida

    Boynton Beach, Florida, 33426

  • Clinical Research Group of Montana

    Bozeman, Montana, 59718

  • PAB Clinical Research

    Brandon, Florida, 33511

  • Connecticut Gastroenterology Institute

    Bristol, Connecticut, 06010

  • Beacon Clinical Research

    Brockton, Massachusetts, 02301

  • UNC Hospitals

    Chapel Hill, North Carolina, 27599

  • Clinsearch, LLC

    Chattanooga, Tennessee, 37421

  • New River Valley Research Institute

    Christiansburg, Virginia, 24073

  • New Jersey Physicians, LLC

    Clifton, New Jersey, 07012

  • Advanced Research Institute

    Clinton, Utah, 84015

  • Clinicos

    Colorado Springs, Colorado, 80904

  • Meridian Clinical Research

    Dakota Dunes, South Dakota, 57049

  • Radiant Research Dallas-North

    Dallas, Texas, 75231

  • Carolinas Research Associates

    Davidson, North Carolina, 28036

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Cumberland Research Associates

    Fayetteville, North Carolina, 28314

  • S & W Clinical Research

    Fort Lauderdale, Florida, 33306

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • Vital Research, Inc.

    Greensboro, North Carolina, 27408

  • Meritus Medical Center

    Hagerstown, Maryland, 21742

  • Carolinas Research Associates

    Harrisburg, North Carolina, 28075

  • Medical Research Unlimited, LLC

    Hialeah, Florida, 33012

  • Peters Medical Research

    High Point, North Carolina, 27262

  • GI Consultants, P.A.

    Houston, Texas, 77034

  • Jupiter Research

    Jupiter, Florida, 33458

  • Clinical Research Center of Nevada

    Las Vegas, Nevada, 89104

  • Family Medical Associates

    Levittown, Pennsylvania, 19056

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72205

  • Preferred Research Partners, Inc

    Little Rock, Arkansas, 72211

  • Advanced Research Institute

    Logan, Utah, 84341

  • Southern California Research Institute Medical Group Inc

    Los Angeles, California, 90045

  • Blue Ridge Medical Center

    Lynchburg, Virginia, 24502

  • Gastrointestinal Specialists of GA, PC

    Marietta, Georgia, 30060

  • Clinical Trials Management

    Metairie, Louisiana, 70006

  • Center for Digestive and Liver Diseases

    Mexico, Missouri, 65265

  • Digestive Research Associates

    Newnan, Georgia, 30263

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Oklahoma Foundation for Digestive Research Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Meridian Clinical Research

    Omaha, Nebraska, 68134

  • Research Integrity

    Owensboro, Kentucky, 42303

  • Pasadena Gastroenterology Assoc, dba Digestive Health Center

    Pasadena, Texas, 77505

  • Pines Clinical Research, Inc.

    Pembroke Pines, Florida, 33028

  • HOPE Research Institute

    Phoenix, Arizona, 85050

  • Radiant Research

    Pinellas Park, Florida, 33781

  • Accord Clinical Research, LLC

    Port Orange, Florida, 32129

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Rockford Gastroenterology Associates, Ltd

    Rockford, Illinois, 61107

  • Office Based Practitioner

    San Antonio, Texas, 78229

  • Medical Center for Clinical Research

    San Diego, California, 92108

  • Advanced Research Institute

    Sandy City, Utah, 84094

  • Guthrie Clinic, Ltd.

    Sayre, Pennsylvania, 18840

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71103

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • Ramstad Medical Associates

    Suffolk, Virginia, 23435

  • Aurora Wilkinson Medical Clinic

    Summit, Wisconsin, 53066

  • Genova Clinical Research

    Tucson, Arizona, 85704

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • Professional Research Network of Kansas, LLC

    Wichita, Kansas, 67203

Other trials in United States

Poland9 sites

  • NZOZ Specjalistyczne Centrum Gastrologii Gastromed

    Bialystok, 15-351

  • Centrum Medyczne im Swietego Lukasza Sp. z o.o.

    Częstochowa, 42-202

  • NZOZ ''Salvia''

    Katowice, 40-772

  • Centrum Medyczne Szpital sw. Rodziny Sp. z o.o.

    Lodz, 90-302

  • Gastromed Sp. K. NZOZ

    Lublin, 20-607

  • Endoskopia Sp. z o.o.

    Sopot, 81-756

  • NZOZ Vivamed

    Warsaw, 03-580

  • Lexmedica

    Wroclaw, 53-025

  • Aktywne Centrum Zdrowia NZOZ ZAWIDAWIE Sp. z o.o.

    Wroclaw, 54-239

Other trials in Poland

Germany7 sites

  • Praxis Dr. Andreas Schwittay-Facharzt fuer Innere Medizin

    Böhlen, 4564

  • Zentrum fur Innere Medizin, Klinikum Garmisch Partenkirchen

    Garmisch-Partenkirchen, 82467

  • Haus der Gesundheit

    Ludwigshafen, 67067

  • Praxis für Gastroenterologie und fachärztliche Innere Medizin

    Ludwigshafen, 67067

  • Medizinische Fakultät der Otto-von-Guericke Universität

    Magdeburg, 39120

  • Gemeinschaftspraxis Dres. Brandt

    Potsdam, 14482

  • Gemeinschaftspraxis Dres Josef und Wilma Großkopf

    Wallerfing, 94574

Other trials in Germany

Latvia4 sites

  • Daugavpils Regional Hospital

    Daugavpils, 5417

  • Pauls Stradins Clinical University Hospital

    Riga, 1002

  • Digestive Disease Centre "Gastro"

    Riga, 1006

  • Vidzemes Hospital

    Valmiera, 4201

Other trials in Latvia

Romania4 sites

  • Brasov County Hospital

    Brasov, 500326

  • Centrul Medical Galenus

    Târgu Mureş, 540098

  • Cabinet Particular Policlinic Algomed SRL

    Timișoara, 300002

  • Policlinica "Dr. Citu" SRL

    Timișoara, 300594

Other trials in Romania

Czechia2 sites

  • Hepato-Gastroenterology HK s.r.o.

    Hradec Králové, 50012

  • Nemocnice Valasske Mezirici a.s.

    Valašské Meziříčí, 75742

Other trials in Czechia

About this study

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

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.

Being tested
SSP-002358 (0.1 mg) + PPI, SSP-002358 (0.5 mg) + PPI, SSP-002358 (2.0 mg) + PPI, Placebo + PPI
Medical subject headings
Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SSP-002358 (0.1 mg) + PPIDrug

    Also called SPD557

    0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI

  • SSP-002358 (0.5 mg) + PPIDrug

    0.5 mg tablet t.i.d. taken in addition to a PPI

  • SSP-002358 (2.0 mg) + PPIDrug

    2.0 mg tablet t.i.d. taken in addition to a PPI

  • Placebo + PPIDrug

    Placebo t.i.d. taken in addition to a PPI

Study groups in NCT01472939
Study groupRoleWhat they receive
SSP-002358 (0.1 mg) + Proton Pump Inhibitor (PPI)Active comparatorNot described
Receives: Drug: SSP-002358 (0.1 mg) + PPI
SSP-002358 (0.5 mg) + PPIActive comparatorNot described
Receives: Drug: SSP-002358 (0.5 mg) + PPI
SSP-002358 (2.0 mg) + PPIActive comparatorNot described
Receives: Drug: SSP-002358 (2.0 mg) + PPI
Placebo + PPIPlacebo comparatorNot described
Receives: Drug: Placebo + PPI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8

    Measured: Baseline and over weeks 5-8

Secondary outcomes (5)

  1. Change From Baseline in Heartburn-Free Days Over Weeks 5-8

    Measured: Baseline and over weeks 5-8

  2. 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.

    Measured: Baseline and over weeks 5-8

  3. 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.

    Measured: Over 8 hours post-dose (week 2 or later)

  4. 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.

    Measured: Over 8 hours post-dose (week 2 or later)

  5. Time to Maximum Plasma Concentration (Tmax) of SSP-002358

    Measured: Over 8 hours post-dose (week 2 or later)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2011 (estimated)
  2. Study start27 Feb 2012
  3. Primary completion14 May 2013
  4. Study completion14 May 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01472939
Sponsor's protocol ID
SPD557-206
Other IDs
2011-004388-62
Status last verified
May 2021
First submitted
14 Nov 2011
Last updated
9 Jun 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25693609

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SSP-002358 (0.1 mg) + PPI, SSP-002358 (0.5 mg) + PPI and SSP-002358 (2.0 mg) + PPI in people with Gastroesophageal Reflux Disease, run by Shire at 88 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Poland, Germany, Latvia, Romania and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8 (time frame: Baseline and over weeks 5-8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01472939, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.

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