Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis
NCT ID: NCT00299013
Last Updated: 2008-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
796 participants
INTERVENTIONAL
2006-03-31
2008-04-30
Brief Summary
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Detailed Description
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This study will investigate whether COLAL-PRED®, a novel dosage form of a prednisolone ester, is safe and effective in the treatment of ulcerative colitis, compared with the standard treatment (conventional prednisolone) and also to determine which dose which will work best for future patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
Prednisolone
Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
2
COLAL-PRED 40mg oral capsule, once daily for 8 weeks.
COLAL-PRED®
COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
3
COLAL-PRED 60mg oral capsule, once daily for 8 weeks.
COLAL-PRED®
COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
4
COLAL-PRED 80mg oral capsule, once daily for 8 weeks.
COLAL-PRED®
COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
Interventions
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COLAL-PRED®
COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
Prednisolone
Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Score of 6-10 on the Disease Activity Index (DAI)
* Moderate to severe mucosal appearance
Exclusion Criteria
* Other treatments for ulcerative colitis that have not been stabilised
* Clinically significant diabetes, heart failure, unstable angina, cirrhosis, renal failure
* History of tuberculosis
18 Years
75 Years
ALL
No
Sponsors
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Alizyme
INDUSTRY
Responsible Party
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Alizyme
Principal Investigators
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Christopher Hawkey
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Nottingham
Locations
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Research Site
Bankstown, New South Wales, Australia
Research Site
Bedford Park, South Australia, Australia
Research Site
Parkville, Victoria, Australia
Research Site
Brussels, , Belgium
Research Site
Ghent, , Belgium
Research Site
Roeselare, , Belgium
Gastroenterologicka ambulance
Hradec Králové, , Czechia
Hepato-Gastroenterologie HK s.r.o.
Hradec Králové, , Czechia
Krajska nemocnice Liberec
Liberec, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Prague, , Czechia
Privatni odborna ambulance
Prague, , Czechia
Oblastni nemocnice Pribram a.s.
Příbram, , Czechia
Okresni nemocnice Tabor
Tábor, , Czechia
Nemocnice v Usti nad Orlici
Ústí nad Orlicí, , Czechia
Research Site
Zlín, , Czechia
Krajska nemocnice T Bati a s
Zlín, , Czechia
Aalborg Hospital
Aalborg, , Denmark
Helsingors Hospital
Elsinore, , Denmark
Gentofte Hospital
Hellerup, , Denmark
Hvidovre Hospital
Hvidovre, , Denmark
CHU Nord Hepato-Gastroenterologie
Amiens, , France
Hopital de l'Archet II
Nice, , France
Hopital Saint Louis
Paris, , France
Hospital Haut Leveque
Pessac, , France
Am Wallgraben 99
Stuttgart, , Germany
Research Site
Debrecen, , Hungary
Research Site
Dunaújváros, , Hungary
Research Site
Eger, , Hungary
Petz Aladar Megyei Korhaz
Győr, , Hungary
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
Gyula, , Hungary
Research Site
Hatvan, , Hungary
Miskolc MJV Semmelweis Korhaz
Miskolc, , Hungary
Research Site
Szekszárd, , Hungary
Fejer Megyei Szent Gyorgy Korhaz
Székesfehérvár, , Hungary
Vas Megyei Markusovszky Korhaz
Szombathely, , Hungary
Research Site
Vác, , Hungary
Research Site
Haifa, , Israel
Research Site
Jerusalem, , Israel
Research Site
Kfar Saba, , Israel
Research Site
Petah Tikva, , Israel
Research Site
Rehovot, , Israel
Research Site
Tel Aviv, , Israel
Policlinico S. Orsola-Malpighi
Bologna, , Italy
Samodzielny Publiczny Szpital Kliniczny, Klinika Gastroenterologii i Chorob Wewnetrznych
Bialystok, , Poland
SP ZOZ Uniwersytecki Szpital Kliniczny Nr 5 im. gen. dyw. Boleslawa Szareckiego Uniwersytetu Medycznego w Lodzi Oddział Gastroenterologii i Chorob Wewnetrznych
Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Klinika Gastroenterologii
Lublin, , Poland
Szpital Kolejowy w Pruszkowie Oddzial Wewnetrzny
Pruszków, , Poland
SPSK Nr 1 im. Prof. Tadeusza Sokolowskiego Pomorskiej Akademii Medycznej Klinika Gastroenterologii i Chorob Wewnetrznych
Szczecin, , Poland
Research Site
Torun, , Poland
Research Site
Warsaw, , Poland
Centrum Onkologii-Instytutu im. Marii Skłodowskiej-Curie Klinika Gastroenterologii
Warsaw, , Poland
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Katedra i Klinika Gastroenterologii i Chorób Przemiany Materii
Warsaw, , Poland
Wojskowy Szpital Kliniczny z Poliklinika Oddzial Gastroenterologii
Wroclaw, , Poland
Research Site
Moscow, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Port Elizabeth, Eastern Cape, South Africa
Research Site
Cape Town, Western Cape, South Africa
Kingsbury Hospital
Cape Town, , South Africa
Panorama Mediclinic
Cape Town, , South Africa
Parklands Medical Centre
Durban, , South Africa
Fordsburg Clinic
Johannesburg, , South Africa
Kloof Medi Clinic
Pretoria, , South Africa
Research Site
Córdoba, Andalusia, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital Universitario del Mar
Barcelona, , Spain
Research Site
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario Joan XXIII
Tarragona, , Spain
Karolinska University Hospital Solna
Stockholm, , Sweden
Sophiahemmet Stockholm
Stockholm, , Sweden
Norrlands University Hospital Umea
Umeå, , Sweden
Addenbrooke's Hospital
Cambridge, , United Kingdom
Research Site
Cottingham, , United Kingdom
Darent Valley Hospital
Dartford, , United Kingdom
Research Site
Edinburgh, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
Leicester General Hospital
Leicester, , United Kingdom
Research Site
Liverpool, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Middlesex Hospital
London, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
University Hospital
Nottingham, , United Kingdom
Hope Hospital
Salford, , United Kingdom
Research Site
Sheffield, , United Kingdom
Countries
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Other Identifiers
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ATL2502/020/CL
Identifier Type: -
Identifier Source: org_study_id