The purpose of this study is to investigate whether a novel dosage form of a prednisolone ester, called COLAL-PRED®, is useful in the treatment of ulcerative colitis...
Date First Received: March 2, 2006
Last Updated: April 24, 2008
Verified by: Alizyme, April 2008
Clinical Trial Phase: Phase 3 | Start Date: March 2006
Overall Status: Completed
Estimated Enrollment: 796
Brief Summary
Official Title: “A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to investigate whether a novel dosage form of a prednisolone ester, called COLAL-PRED®, is useful in the treatment of ulcerative colitis.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Detailed Clinical Trial Description
Ulcerative colitis is a disease that causes inflammation of the large bowel, causing fever, diarrhoea, dehydration and other symptoms. Standard treatment for ulcerative colitis includes general medical treatments such as fluid and salt replacement and attention to diet.
Anti-inflammatory medicines such as steroids (e.g. prednisolone) and aminosalicylates (e.g.
mesalazine) are the main drug treatments.
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.
Outcome Measures for this Clinical Trial
Primary:
- Disease activity index After 4 and 8 weeks of treatment No
- Cortisol levels After 4 and 8 weeks of treatment Yes
Secondary:
- Simple clinical colitis activity index 8 weeks No
- Endoscopy 8 weeks No
- Adverse events 12 weeks Yes
- Laboratory tests 12 weeks Yes
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Endoscopically confirmed diagnosis of ulcerative colitis
- Score of 6-10 on the Disease Activity Index (DAI)
- Moderate to severe mucosal appearance
Exclusion Criteria:
- Previous colonic surgery
- Other treatments for ulcerative colitis that have not been stabilised
- Clinically significant diabetes, heart failure, unstable angina, cirrhosis, renal failure
- History of tuberculosis
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Alizyme
Research Site
Bankstown New South Wales 2200 Australia
Research Site
Bedford Park South Australia 5042 Australia
Research Site
Parkville Victoria 3050 Australia
Research Site
Roeselare 8800 Belgium
Research Site
Gent 9000 Belgium
Research Site
Bruxelles 1070 Belgium
Oblastni nemocnice Pribram a.s.
Pribram Czech Republic
Krajska nemocnice Liberec
Liberec Czech Republic
Privatni odborna ambulance
Prague Czech Republic
Gastroenterologicka ambulance
Hradec Kralove Czech Republic
Hepato-Gastroenterologie HK s.r.o.
Hradec Kralove Czech Republic
Nemocnice v Usti nad Orlici
Usti nad Orlici Czech Republic
Okresni nemocnice Tabor
Tabor Czech Republic
Krajska nemocnice T Bati a s
Zlin Czech Republic
Research Site
Olomouc 77520 Czech Republic
Research Site
Praha 10 100 34 Czech Republic
Research Site
Zlin 762 75 Czech Republic
Aalborg Hospital
Aalborg Denmark
Helsingors Hospital
Helsingor Denmark
Gentofte Hospital
Hellerup Denmark
Hvidovre Hospital
Hvidovre Denmark
Hospital Haut Leveque
Pessac France
CHU Nord Hepato-Gastroenterologie
Amiens France
Hopital de l'Archet II
Nice France
Hopital Saint Louis
Paris France
Am Wallgraben 99
Stuttgart Germany
Petz Aladar Megyei Korhaz
Gyor Hungary
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
Gyula Hungary
Vas Megyei Markusovszky Korhaz
Szombathely Hungary
Miskolc MJV Semmelweis Korhaz
Miskolc Hungary
Fejer Megyei Szent Gyorgy Korhaz
Székesfehérvár Hungary
Research Site
Szekszard H-7100 Hungary
Research Site
Debrecen H-4012 Hungary
Research Site
Eger H-3300 Hungary
Research Site
Vac H-2601 Hungary
Research Site
Hatvan H-3000 Hungary
Research Site
Dunaujvaros H-2400 Hungary
Research Site
Kfar Saba 44281 Israel
Research Site
Petah-Tikva Israel
Research Site
Rehovot 76100 Israel
Research Site
Tel-Aviv Israel
Research Site
Haifa 31096 Israel
Research Site
Jerusalem 91031 Israel
Policlinico S. Orsola-Malpighi
Bologna Italy
Samodzielny Publiczny Szpital Kliniczny, Klinika Gastroenterologii i Chorob Wewnetrznych
Bialystok Poland
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Katedra i Klinika Gastroenterologii i Chorób Przemiany Materii
Warszawa Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Klinika Gastroenterologii
Lublin Poland
Szpital Kolejowy w Pruszkowie Oddzial Wewnetrzny
Pruszkow Poland
Centrum Onkologii-Instytutu im. Marii Skłodowskiej-Curie Klinika Gastroenterologii
Warszawa Poland
Wojskowy Szpital Kliniczny z Poliklinika Oddzial Gastroenterologii
Wroclaw Poland
SPSK Nr 1 im. Prof. Tadeusza Sokolowskiego Pomorskiej Akademii Medycznej Klinika Gastroenterologii i Chorob Wewnetrznych
Szczecin Poland
SP ZOZ Uniwersytecki Szpital Kliniczny Nr 5 im. gen. dyw. Boleslawa Szareckiego Uniwersytetu Medycznego w Lodzi Oddział Gastroenterologii i Chorob Wewnetrznych
Lodz Poland
Research Site
Torun 87-100 Poland
Research Site
Warszawa 03-563 Poland
Research Site
Moscow 105203 Russian Federation
Research Site
St. Petersburg 195067 Russian Federation
Kingsbury Hospital
Cape Town South Africa
Kloof Medi Clinic
Pretoria South Africa
Parklands Medical Centre
Durban South Africa
Panorama Mediclinic
Cape Town South Africa
Fordsburg Clinic
Johannesburg South Africa
Research Site
Port Elizabeth Eastern Cape 6057 South Africa
Research Site
Cape Town Western Cape South Africa
Hospital Universitario Joan XXIII
Tarragona Spain
Hospital Clínico San Carlos
Madrid Spain
Hospital Clinic i Provincial de Barcelona
Barcelona Spain
Hospital Universitario del Mar
Barcelona Spain
Research Site
Madrid 28034 Spain
Research Site
Cordoba Andalucia 14004 Spain
Norrlands University Hospital Umea
Umea Sweden
Karolinska University Hospital Solna
Stockholm Sweden
Sophiahemmet Stockholm
Stockholm Sweden
University Hospital
Nottingham United Kingdom
Leeds General Infirmary
Leeds United Kingdom
Hope Hospital
Salford United Kingdom
Leicester General Hospital
Leicester United Kingdom
Darent Valley Hospital
Dartford United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne United Kingdom
Hammersmith Hospital
London United Kingdom
Addenbrooke's Hospital
Cambridge United Kingdom
Middlesex Hospital
London United Kingdom
Western General Hospital
Edinburgh United Kingdom
Research Site
Sheffield S10 2JF United Kingdom
Research Site
Cottingham HU16 5JQ United Kingdom
Research Site
Liverpool L7 8XP United Kingdom
Research Site
Edinburgh EH16 4SA United Kingdom
Overall Clinical Trial Officials and Contacts
Christopher Hawkey Principal Investigator University Hospital, Nottingham
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00299013
Study ID Number: ATL2502/020/CL
ClinicalTrials.gov Identifier: NCT00299013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
