Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis

PHASE3CompletedINTERVENTIONAL
Enrollment

829

Participants

Timeline

Start Date

April 8, 2005

Primary Completion Date

September 7, 2009

Study Completion Date

September 7, 2009

Conditions
Ulcerative Colitis
Interventions
DRUG

SPD476

2.4 g/day Once Daily (QD)

DRUG

Asacol

1.6g/day administered 800 mg Twice Daily (BID)

Trial Locations (142)

112

Taipei Veterans General Hospital, Taipei

620

Shakespeare Specialist Group, Auckland

1400

Bispebjerg Hospital, Copenhagen NV

2001

Waikato DHB Hospital, Hamilton

2139

Concord Hospital, Concord

2193

Milpark Hospital, Johannesburg

2200

Bankstown-Lidcombe Hospital, Bankstown

2650

Hvidovre Hospital, Hvidovre

2820

Imelda General Hospital, Bonheiden

3065

St Vincent's Hospital, Fitzroy

3112

Tauranga Hospital BOP Medical, Tauranga

3128

Eastern Health Hospital, Box Hill

3600

Ziekenhuis Oost Limburg, Genk

4001

St Augustine's Hospital, Durban

4091

Parklands Medical Centre, Durban

4600

Koge University Hospital, Køge

5000

Royal Adelaide Hospital, Adelaide

6057

Greenacres Hospital, Port Elizabeth

6160

Fremantle Hospital, Fremantle

6242

Wellington Hospital, Wellington

6700

Mexican Institute of Clinical Research, Mexico City

7130

2H Arun Place, Somerset West

7505

Louis Leipoldt Medical Centre, Bellville

7708

Kingsbury Hospital, Cape Town

7925

New Groote Schuur Hospital, Observatory

8800

Heilig Hart ziekenhuis vzw Roeselare-Menen, Roeselare

10002

National Taiwan University Hospital, Taipei

11042

New York Center for Clinical Research, Lake Success

11486

Sophiahemmet, Stockholm

14004

Hospital Universitario Reina Sofia, Córdoba

14059

Thomavers Hospital, Prague

14186

Karolinska University Hospital, Stockholm

17176

Karolinska University Hospital, Stockholm

20010

Washington Gastroenterology, Washington D.C.

23090

Central de Especialidades Medicas (FIDEPAZ), La Paz

27250

Hospital Angeles Torreón, Torreón

28034

Hospital Universitario Ramon Y Cajal, Madrid

30342

Atlanta Gastroenterology Associates, Atlanta

30460

Fakultni Nemocnice Plzen, Pilsen

32168

United Medical Research, New Smyrna Beach

32256

Boorland-Groover Clinic, Jacksonville

33021

Southern Clinical Research Consultants, Hollywood

35209

Birmingham Gastroenterology Associates, Birmingham

37404

ClinSearch, Chattanooga

40705

Taichung Veterans General Hospital, Taichung

41345

Sahlgrenska University Hospital, Gothenburg

44670

Hospital San Javier, Guadalajara

52807

Gastrointestinal Clinic of Quad Cities, Davenport

55905

Mayo Clinic, Rochester

61265

Midwest Clinical Research Center, Moline

65265

Center for Digestive and Liver Diseases, Inc, Mexico

70006

Drug Research Services, Inc., Metairie

77090

S D Khan, Houston

169608

Singapore General Hospital, Singapore

302001

S.R. Kalla Memorial Gastro & General Hospital, Jaipur

308433

Tan Tock Seng Hospital, Singapore

400162

Octavian Fodor Clinical Emergency Hospital, Cluj-Napoca

500082

Asian Institute of Gastreoenterology, Hyderabaad

529889

Changi General Hospital, Singapore

540103

Clinical County Emergency Hospital, Târgu Mureş

600096

Lifeline Multispeciality Hospital, Chennai

695607

Sree Gokulam Medical Centre & Research Foundation, Trivandrum

700111

Institute of Gastronenterology & Hepatology, Iași

900591

County Emergency Hospital, Constanța

7500922

Hospital del Salvador, Santiago

7591046

Clinica Las Condes, Santiago

8330024

Hospital Clinico P.UC, Santiago

8350533

Hospital San Juan de Dios, Santiago

06010

Connecticut Gastroenterology Institute, Bristol

C1181ACH

Hospital Italiano de Buenos Aires, Capital Federal

C1425EUG

Centro Integral De Gastroenterologia, Ciudad de Buenos Aires

M5519GLU

Hospital Italiano de Mendoza, FINAMED SA, Mendoza

13070-040

Unigastro, Castelo

Unknown

Hospital de Clinicas, Porto Alegre

CHU de Grenoble, Grenoble

Hospital De L'Archet, Nice

Hospital Haut Leveque, Pessac

Universitatsklinikum Freiburg, Freiburg im Breisgau

Universitat des Saarlandes, Homburg

Gastroenterologische Praxis Prof. Hackelsberger, Wiesbaden

Klinika Gastroenterologi, Bialystok

Klinika Gastroenterologii, Lodz

Klinika Gastroenterologii, Szczecin

Miejska Przychodnia Specjalistyczna, Torun

Katedra i Klinika Gastroenterologii, Warsaw

City Hospital #24, Moscow

City Hospital #51, Moscow

Scientific Centre of Coloproctology, Moscow

City Hospital #122, Saint Petersburg

Russian Academy of Sciences, Saint Petersburg

Asan Medical Center, Seoul

Yonsei University, College of Medicine, Seoul

Hospital de Sagunto, Valencia

21941-290

Universidade Federal do Rio de Janeiro, Rio de Janeiro

40110-060

Universidade Federal da Bahia - Hospital, Salvador

01244-020

Hospital Sao Paulo, São Paulo

05651-901

Hospital Israelita Albert Einstein, São Paulo

T2N 4NI

University of Calgary, Calgary

M3N2V7

Toronto Digestive Disease Associates, Inc., Toronto

H1T2M4

Hopital Maisonneuve-Rosemont, Montreal

G1R 2J6

Hópital Hótel-Dieu de Quebec, Québec

T5H4B9

GI Research, Edmonton

120 00

NZZ Online 24 s.r.o, Prague

140 00

Remedis s.r.o, Prague

170 04

Klinicke Centrum ISCARE I.V.F, Prague

466 60

Nemocnice Jablonec nad Nisou p.o, Prague

261 26

Oblastni Nemocnice Pribram, Příbram

390 03

Nemocnice Tabor A.S., Tábor

401 13

Masarykova Nemocnice, Ústí nad Labem

H-1076

Peterfy Sandor utcai, Budapest

H-1083

Semmelweis Egyetem, Budapest

H-4012

Debreceni Egyetem OEC - III, Debrecen

H-3300

Markhot Ferenc Korhaz-Rendelointeze II. Belgyogyaszat - Gasztroenterologia, Eger

H-5700

Pandy Kalman County Hospital, Gyula

682 026

Amrita Institute of Medical Sciences, Kochi

226 014

Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow

141 001

Dayanand Medical College and Hospital, Ludhiana

400 026

Jaslok Hospital and Research Centre, Mumbai

110 029

All India Institute of Medical Sciences, New Delhi

CP23000

Unidad Medica de Endoscopia y Cirugia (UNIMEDEC), La Paz

CP 14000

Instituto Nacional de Ciencias médicas y Nutrición Salvador Zubirán, Mexico City

6162 BG

Orbis Medical Centre, Sittard

8025 AB

Isala Clinics, Zwolle

Lima-11

Hospital Nacional Edgardo Rebagliati Martins, Lima

Lima-13

Hospital Nacional Guillermo Alemnara Irigoyen, Lima

Lima-27

Clinica Anglo America, Lima

Clinica El Golf, Lima

4701-965

Hospital Sao Marcos, Braga

1349-019

Hospital Egas Moniz, Lisbon

4099-001

Hospital Geral Santo Antonio, Porto

020125

Colentina Clinical Hospital, Bucharest

021392

Prf. Dr D. Gerota Emergency Hospital, Bucharest

431-070

Hallyam University, Sacred Heart Hospital, Anyang-si

110-744

Seoul National University Hospital, Seoul

135-710

Samsung Medical Centre, Seoul

137-040

The Catholic University of Korea Kangnam St Mary's Hospital, Seoul

08916

Hospital Universitario Germans Trias I Pujol, Badalona

HA1 3UJ

St. Mark's Hospital, Harrow

CB2 2QQ

Addenbrookes Hospital Department of Gastroenterology, Cambridge

W12 0NN

Imperial College School of Medicine, London

NE1 4LP

Royal Victoria Infirmary, Newcastle upon Tyne

S10 2JF

Royal Hallamshire Hospital, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY