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

PHASE2CompletedINTERVENTIONAL
Enrollment

480

Participants

Timeline

Start Date

February 27, 2012

Primary Completion Date

May 14, 2013

Study Completion Date

May 14, 2013

Conditions
Gastroesophageal Reflux Disease
Interventions
DRUG

SSP-002358 (0.1 mg) + PPI

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

DRUG

SSP-002358 (0.5 mg) + PPI

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

DRUG

SSP-002358 (2.0 mg) + PPI

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

DRUG

Placebo + PPI

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

Trial Locations (88)

1002

Pauls Stradins Clinical University Hospital, Riga

1006

"Digestive Disease Centre Gastro", Riga

4201

Vidzemes Hospital, Valmiera

4564

Praxis Dr. Andreas Schwittay-Facharzt fuer Innere Medizin, Böhlen

5417

Daugavpils Regional Hospital, Daugavpils

14482

Gemeinschaftspraxis Dres. Brandt, Potsdam

18840

Guthrie Clinic, Ltd., Sayre

19056

Family Medical Associates, Levittown

21742

Meritus Medical Center, Hagerstown

23435

Ramstad Medical Associates, Suffolk

24073

New River Valley Research Institute, Christiansburg

24502

Blue Ridge Medical Center, Lynchburg

27262

Peters Medical Research, High Point

27408

Vital Research, Inc., Greensboro

27599

UNC Hospitals, Chapel Hill

27612

Wake Research Associates, Raleigh

28036

Carolinas Research Associates, Davidson

28075

Carolinas Research Associates, Harrisburg

28314

Cumberland Research Associates, Fayetteville

30060

Gastrointestinal Specialists of GA, PC, Marietta

30263

Digestive Research Associates, Newnan

32129

Accord Clinical Research, LLC, Port Orange

32720

Avail Clinical Research, LLC, DeLand

33012

Medical Research Unlimited, LLC, Hialeah

33028

Pines Clinical Research, Inc., Pembroke Pines

33180

Medical Research Unlimited, LLC, Aventura

33306

S & W Clinical Research, Fort Lauderdale

33426

Consultants for Clinical Research of South Florida, Boynton Beach

33458

Jupiter Research, Jupiter

33511

PAB Clinical Research, Brandon

33709

Meridien Research, St. Petersburg

33781

Radiant Research, Pinellas Park

37421

Clinsearch, LLC, Chattanooga

39120

Medizinische Fakultät der Otto-von-Guericke Universität, Magdeburg

42303

Research Integrity, Owensboro

45005

Prestige Clinical Research, Franklin

50012

Hepato-Gastroenterology HK s.r.o., Hradec Králové

53066

Aurora Wilkinson Medical Clinic, Summit

57049

Meridian Clinical Research, Dakota Dunes

59718

Clinical Research Group of Montana, Bozeman

61107

Rockford Gastroenterology Associates, Ltd, Rockford

65265

Center for Digestive and Liver Diseases, Mexico

67067

Haus der Gesundheit, Ludwigshafen

Praxis für Gastroenterologie und fachärztliche Innere Medizin, Ludwigshafen

67203

Professional Research Network of Kansas, LLC, Wichita

68134

Meridian Clinical Research, Omaha

70006

Clinical Trials Management, Metairie

71103

Louisiana Research Center, LLC, Shreveport

72117

Arkansas Gastroenterology, North Little Rock

72205

Lynn Institute of the Ozarks, Little Rock

72211

Preferred Research Partners, Inc, Little Rock

73104

Oklahoma Foundation for Digestive Research Sciences Center, Oklahoma City

75231

Radiant Research Dallas-North, Dallas

75742

Nemocnice Valasske Mezirici a.s., Valašské Meziříčí

77034

GI Consultants, P.A., Houston

77505

Pasadena Gastroenterology Assoc, dba Digestive Health Center, Pasadena

78229

Office Based Practitioner, San Antonio

80904

Clinicos, Colorado Springs

82467

Zentrum fur Innere Medizin, Klinikum Garmisch Partenkirchen, Garmisch-Partenkirchen

84015

Advanced Research Institute, Clinton

84094

Advanced Research Institute, Sandy City

84341

Advanced Research Institute, Logan

84405

Advanced Research Institute, Ogden

85050

HOPE Research Institute, Phoenix

85704

Genova Clinical Research, Tucson

89104

Clinical Research Center of Nevada, Las Vegas

90045

Southern California Research Institute Medical Group Inc, Los Angeles

92108

Medical Center for Clinical Research, San Diego

94574

Gemeinschaftspraxis Dres Josef und Wilma Großkopf, Wallerfing

300002

Cabinet Particular Policlinic Algomed SRL, Timișoara

300594

"Policlinica Dr. Citu SRL", Timișoara

500326

Brasov County Hospital, Brasov

540098

Centrul Medical Galenus, Târgu Mureş

92801-2417

Anaheim Clinical Trials, Anaheim

06010

Connecticut Gastroenterology Institute, Bristol

06905

Stamford Therapeutics Consortium, Stamford

02301

Beacon Clinical Research, Brockton

07012

New Jersey Physicians, LLC, Clifton

02886

Omega Medical Research, Warwick

15-351

NZOZ Specjalistyczne Centrum Gastrologii Gastromed, Bialystok

42-202

Centrum Medyczne im Swietego Lukasza Sp. z o.o., Częstochowa

40-772

NZOZ ''Salvia'', Katowice

90-302

Centrum Medyczne Szpital sw. Rodziny Sp. z o.o., Lodz

20-607

Gastromed Sp. K. NZOZ, Lublin

81-756

Endoskopia Sp. z o.o., Sopot

03-580

NZOZ Vivamed, Warsaw

53-025

Lexmedica, Wroclaw

54-239

Aktywne Centrum Zdrowia NZOZ ZAWIDAWIE Sp. z o.o., Wroclaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT01472939 - Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD) | Biotech Hunter | Biotech Hunter