Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis
A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis
1 other identifier
interventional
796
15 countries
86
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2006
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 2, 2006
CompletedFirst Posted
Study publicly available on registry
March 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedApril 25, 2008
April 1, 2008
2.1 years
March 2, 2006
April 24, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Disease activity index
After 4 and 8 weeks of treatment
Cortisol levels
After 4 and 8 weeks of treatment
Secondary Outcomes (4)
Simple clinical colitis activity index
8 weeks
Endoscopy
8 weeks
Adverse events
12 weeks
Laboratory tests
12 weeks
Study Arms (4)
1
ACTIVE COMPARATORPrednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
2
EXPERIMENTALCOLAL-PRED 40mg oral capsule, once daily for 8 weeks.
3
EXPERIMENTALCOLAL-PRED 60mg oral capsule, once daily for 8 weeks.
4
EXPERIMENTALCOLAL-PRED 80mg oral capsule, once daily for 8 weeks.
Interventions
COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
Eligibility Criteria
You may qualify if:
- Endoscopically confirmed diagnosis of ulcerative colitis
- Score of 6-10 on the Disease Activity Index (DAI)
- Moderate to severe mucosal appearance
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alizymelead
Study Sites (86)
Research Site
Bankstown, New South Wales, 2200, Australia
Research Site
Bedford Park, South Australia, 5042, Australia
Research Site
Parkville, Victoria, 3050, Australia
Research Site
Brussels, 1070, Belgium
Research Site
Ghent, 9000, Belgium
Research Site
Roeselare, 8800, Belgium
Gastroenterologicka ambulance
Hradec Králové, Czechia
Hepato-Gastroenterologie HK s.r.o.
Hradec Králové, Czechia
Krajska nemocnice Liberec
Liberec, Czechia
Research Site
Olomouc, 77520, Czechia
Research Site
Prague, 100 34, 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, 762 75, 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, H-4012, Hungary
Research Site
Dunaújváros, H-2400, Hungary
Research Site
Eger, H-3300, Hungary
Petz Aladar Megyei Korhaz
Győr, Hungary
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
Gyula, Hungary
Research Site
Hatvan, H-3000, Hungary
Miskolc MJV Semmelweis Korhaz
Miskolc, Hungary
Research Site
Szekszárd, H-7100, Hungary
Fejer Megyei Szent Gyorgy Korhaz
Székesfehérvár, Hungary
Vas Megyei Markusovszky Korhaz
Szombathely, Hungary
Research Site
Vác, H-2601, Hungary
Research Site
Haifa, 31096, Israel
Research Site
Jerusalem, 91031, Israel
Research Site
Kfar Saba, 44281, Israel
Research Site
Petah Tikva, Israel
Research Site
Rehovot, 76100, 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, 87-100, Poland
Research Site
Warsaw, 03-563, 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, 105203, Russia
Research Site
Saint Petersburg, 195067, Russia
Research Site
Port Elizabeth, Eastern Cape, 6057, 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, 14004, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
Hospital Universitario del Mar
Barcelona, Spain
Research Site
Madrid, 28034, 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, HU16 5JQ, United Kingdom
Darent Valley Hospital
Dartford, United Kingdom
Research Site
Edinburgh, EH16 4SA, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
Leicester General Hospital
Leicester, United Kingdom
Research Site
Liverpool, L7 8XP, 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, S10 2JF, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Hawkey
University Hospital, Nottingham
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 2, 2006
First Posted
March 6, 2006
Study Start
March 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
April 25, 2008
Record last verified: 2008-04