Clinical trial NCT00299013: Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
Lead sponsor: Alizyme
Sponsor class: INDUSTRY
First posted: 2006-03-06
Enrollment: 796
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease activity index
timeFrame: After 4 and 8 weeks of treatment
measure: Cortisol levels
timeFrame: After 4 and 8 weeks of treatment
Secondary outcomes:
measure: Simple clinical colitis activity index
timeFrame: 8 weeks
measure: Endoscopy
timeFrame: 8 weeks
measure: Adverse events
timeFrame: 12 weeks
measure: Laboratory tests
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bankstown
country: Australia
facility: Research Site
state: New South Wales
city: Bedford Park
country: Australia
facility: Research Site
state: South Australia
city: Parkville
country: Australia
facility: Research Site
state: Victoria
city: Bruxelles
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Roeselare
country: Belgium
facility: Research Site
city: Hradec Kralove
country: Czech Republic
facility: Gastroenterologicka ambulance
city: Hradec Kralove
country: Czech Republic
facility: Hepato-Gastroenterologie HK s.r.o.
city: Liberec
country: Czech Republic
facility: Krajska nemocnice Liberec
city: Olomouc
country: Czech Republic
facility: Research Site
city: Prague
country: Czech Republic
facility: Privatni odborna ambulance
city: Praha 10
country: Czech Republic
facility: Research Site
city: Pribram
country: Czech Republic
facility: Oblastni nemocnice Pribram a.s.
city: Tabor
country: Czech Republic
facility: Okresni nemocnice Tabor
city: Usti nad Orlici
country: Czech Republic
facility: Nemocnice v Usti nad Orlici
city: Zlin
country: Czech Republic
facility: Research Site
city: Zlin
country: Czech Republic
facility: Krajska nemocnice T Bati a s
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Helsingor
country: Denmark
facility: Helsingors Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Amiens
country: France
facility: CHU Nord Hepato-Gastroenterologie
city: Nice
country: France
facility: Hopital de l'Archet II
city: Paris
country: France
facility: Hopital Saint Louis
city: Pessac
country: France
facility: Hospital Haut Leveque
city: Stuttgart
country: Germany
facility: Am Wallgraben 99
city: Debrecen
country: Hungary
facility: Research Site
city: Dunaujvaros
country: Hungary
facility: Research Site
city: Eger
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Korhaz
city: Gyula
country: Hungary
facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza
city: Hatvan
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Miskolc MJV Semmelweis Korhaz
city: Szekszard
country: Hungary
facility: Research Site
city: Szombathely
country: Hungary
facility: Vas Megyei Markusovszky Korhaz
city: Székesfehérvár
country: Hungary
facility: Fejer Megyei Szent Gyorgy Korhaz
city: Vac
country: Hungary
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Kfar Saba
country: Israel
facility: Research Site
city: Petah-Tikva
country: Israel
facility: Research Site
city: Rehovot
country: Israel
facility: Research Site
city: Tel-Aviv
country: Israel
facility: Research Site
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi
city: Bialystok
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny, Klinika Gastroenterologii i Chorob Wewnetrznych
city: Lodz
country: Poland
facility: SP ZOZ Uniwersytecki Szpital Kliniczny Nr 5 im. gen. dyw. Boleslawa Szareckiego Uniwersytetu Medycznego w Lodzi Oddział Gastroenterologii i Chorob Wewnetrznych
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Klinika Gastroenterologii
city: Pruszkow
country: Poland
facility: Szpital Kolejowy w Pruszkowie Oddzial Wewnetrzny
city: Szczecin
country: Poland
facility: SPSK Nr 1 im. Prof. Tadeusza Sokolowskiego Pomorskiej Akademii Medycznej Klinika Gastroenterologii i Chorob Wewnetrznych
city: Torun
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytutu im. Marii Skłodowskiej-Curie Klinika Gastroenterologii
city: Warszawa
country: Poland
facility: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Katedra i Klinika Gastroenterologii i Chorób Przemiany Materii
city: Wroclaw
country: Poland
facility: Wojskowy Szpital Kliniczny z Poliklinika Oddzial Gastroenterologii
city: Moscow
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Port Elizabeth
country: South Africa
facility: Research Site
state: Eastern Cape
city: Cape Town
country: South Africa
facility: Research Site
state: Western Cape
city: Cape Town
country: South Africa
facility: Kingsbury Hospital
city: Cape Town
country: South Africa
facility: Panorama Mediclinic
city: Durban
country: South Africa
facility: Parklands Medical Centre
city: Johannesburg
country: South Africa
facility: Fordsburg Clinic
city: Pretoria
country: South Africa
facility: Kloof Medi Clinic
city: Cordoba
country: Spain
facility: Research Site
state: Andalucia
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario del Mar
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Tarragona
country: Spain
facility: Hospital Universitario Joan XXIII
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
city: Stockholm
country: Sweden
facility: Sophiahemmet Stockholm
city: Umea
country: Sweden
facility: Norrlands University Hospital Umea
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Cottingham
country: United Kingdom
facility: Research Site
city: Dartford
country: United Kingdom
facility: Darent Valley Hospital
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: London
country: United Kingdom
facility: Middlesex Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Nottingham
country: United Kingdom
facility: University Hospital
city: Salford
country: United Kingdom
facility: Hope Hospital
city: Sheffield
country: United Kingdom
facility: Research Site
Study officials:
affiliation: University Hospital, Nottingham
name: Christopher Hawkey
role: PRINCIPAL_INVESTIGATOR
References: