Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis

PHASE3CompletedINTERVENTIONAL
Enrollment

796

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

April 30, 2008

Study Completion Date

April 30, 2008

Conditions
Ulcerative Colitis
Interventions
DRUG

COLAL-PRED®

COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.

DRUG

Prednisolone

Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.

Trial Locations (86)

1070

Research Site, Brussels

2200

Research Site, Bankstown

3050

Research Site, Parkville

5042

Research Site, Bedford Park

6057

Research Site, Port Elizabeth

8800

Research Site, Roeselare

9000

Research Site, Ghent

14004

Research Site, Córdoba

28034

Research Site, Madrid

31096

Research Site, Haifa

44281

Research Site, Kfar Saba

76100

Research Site, Rehovot

77520

Research Site, Olomouc

91031

Research Site, Jerusalem

105203

Research Site, Moscow

195067

Research Site, Saint Petersburg

Unknown

Gastroenterologicka ambulance, Hradec Králové

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

Krajska nemocnice Liberec, Liberec

Privatni odborna ambulance, Prague

Oblastni nemocnice Pribram a.s., Příbram

Okresni nemocnice Tabor, Tábor

Nemocnice v Usti nad Orlici, Ústí nad Orlicí

Krajska nemocnice T Bati a s, Zlín

Aalborg Hospital, Aalborg

Helsingors Hospital, Elsinore

Gentofte Hospital, Hellerup

Hvidovre Hospital, Hvidovre

CHU Nord Hepato-Gastroenterologie, Amiens

Hopital de l'Archet II, Nice

Hopital Saint Louis, Paris

Hospital Haut Leveque, Pessac

Am Wallgraben 99, Stuttgart

Petz Aladar Megyei Korhaz, Győr

Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Gyula

Miskolc MJV Semmelweis Korhaz, Miskolc

Fejer Megyei Szent Gyorgy Korhaz, Székesfehérvár

Vas Megyei Markusovszky Korhaz, Szombathely

Research Site, Petah Tikva

Research Site, Tel Aviv

Policlinico S. Orsola-Malpighi, Bologna

Samodzielny Publiczny Szpital Kliniczny, Klinika Gastroenterologii i Chorob Wewnetrznych, Bialystok

SP ZOZ Uniwersytecki Szpital Kliniczny Nr 5 im. gen. dyw. Boleslawa Szareckiego Uniwersytetu Medycznego w Lodzi Oddział Gastroenterologii i Chorob Wewnetrznych, Lodz

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Klinika Gastroenterologii, Lublin

Szpital Kolejowy w Pruszkowie Oddzial Wewnetrzny, Pruszków

SPSK Nr 1 im. Prof. Tadeusza Sokolowskiego Pomorskiej Akademii Medycznej Klinika Gastroenterologii i Chorob Wewnetrznych, Szczecin

Centrum Onkologii-Instytutu im. Marii Skłodowskiej-Curie Klinika Gastroenterologii, Warsaw

Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Katedra i Klinika Gastroenterologii i Chorób Przemiany Materii, Warsaw

Wojskowy Szpital Kliniczny z Poliklinika Oddzial Gastroenterologii, Wroclaw

Research Site, Cape Town

Kingsbury Hospital, Cape Town

Panorama Mediclinic, Cape Town

Parklands Medical Centre, Durban

Fordsburg Clinic, Johannesburg

Kloof Medi Clinic, Pretoria

Hospital Clinic i Provincial de Barcelona, Barcelona

Hospital Universitario del Mar, Barcelona

Hospital Clínico San Carlos, Madrid

Hospital Universitario Joan XXIII, Tarragona

Karolinska University Hospital Solna, Stockholm

Sophiahemmet Stockholm, Stockholm

Norrlands University Hospital Umea, Umeå

Addenbrooke's Hospital, Cambridge

Darent Valley Hospital, Dartford

Western General Hospital, Edinburgh

Leeds General Infirmary, Leeds

Leicester General Hospital, Leicester

Hammersmith Hospital, London

Middlesex Hospital, London

Royal Victoria Infirmary, Newcastle upon Tyne

University Hospital, Nottingham

Hope Hospital, Salford

100 34

Research Site, Prague

762 75

Research Site, Zlín

H-4012

Research Site, Debrecen

H-2400

Research Site, Dunaújváros

H-3300

Research Site, Eger

H-3000

Research Site, Hatvan

H-7100

Research Site, Szekszárd

H-2601

Research Site, Vác

87-100

Research Site, Torun

03-563

Research Site, Warsaw

HU16 5JQ

Research Site, Cottingham

EH16 4SA

Research Site, Edinburgh

L7 8XP

Research Site, Liverpool

S10 2JF

Research Site, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Alizyme

INDUSTRY

NCT00299013 - Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis | Biotech Hunter | Biotech Hunter