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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00299013
• Other study ID #: ATL2502/020/CL
• Status: Completed
• Phase: Phase 3
• First received: March 2, 2006
• Last updated: April 24, 2008
• Start date: March 2006
• Est. completion date: April 2008

Study information

• Verified date: April 2008
• Source: Alizyme
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 796
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Australia	Research Site	Bankstown	New South Wales
Australia	Research Site	Bedford Park	South Australia
Australia	Research Site	Parkville	Victoria
Belgium	Research Site	Bruxelles
Belgium	Research Site	Gent
Belgium	Research Site	Roeselare
Czech Republic	Gastroenterologicka ambulance	Hradec Kralove
Czech Republic	Hepato-Gastroenterologie HK s.r.o.	Hradec Kralove
Czech Republic	Krajska nemocnice Liberec	Liberec
Czech Republic	Research Site	Olomouc
Czech Republic	Privatni odborna ambulance	Prague
Czech Republic	Research Site	Praha 10
Czech Republic	Oblastni nemocnice Pribram a.s.	Pribram
Czech Republic	Okresni nemocnice Tabor	Tabor
Czech Republic	Nemocnice v Usti nad Orlici	Usti nad Orlici
Czech Republic	Krajska nemocnice T Bati a s	Zlin
Czech Republic	Research Site	Zlin
Denmark	Aalborg Hospital	Aalborg
Denmark	Gentofte Hospital	Hellerup
Denmark	Helsingors Hospital	Helsingor
Denmark	Hvidovre Hospital	Hvidovre
France	CHU Nord Hepato-Gastroenterologie	Amiens
France	Hopital de l'Archet II	Nice
France	Hopital Saint Louis	Paris
France	Hospital Haut Leveque	Pessac
Germany	Am Wallgraben 99	Stuttgart
Hungary	Research Site	Debrecen
Hungary	Research Site	Dunaujvaros
Hungary	Research Site	Eger
Hungary	Petz Aladar Megyei Korhaz	Gyor
Hungary	Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza	Gyula
Hungary	Research Site	Hatvan
Hungary	Miskolc MJV Semmelweis Korhaz	Miskolc
Hungary	Fejer Megyei Szent Gyorgy Korhaz	Székesfehérvár
Hungary	Research Site	Szekszard
Hungary	Vas Megyei Markusovszky Korhaz	Szombathely
Hungary	Research Site	Vac
Israel	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
Italy	Policlinico S. Orsola-Malpighi	Bologna
Poland	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 Oddzial Gastroenterologii i Chorob Wewnetrznych	Lodz
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Klinika Gastroenterologii	Lublin
Poland	Szpital Kolejowy w Pruszkowie Oddzial Wewnetrzny	Pruszkow
Poland	SPSK Nr 1 im. Prof. Tadeusza Sokolowskiego Pomorskiej Akademii Medycznej Klinika Gastroenterologii i Chorob Wewnetrznych	Szczecin
Poland	Research Site	Torun
Poland	Centrum Onkologii-Instytutu im. Marii Sklodowskiej-Curie Klinika Gastroenterologii	Warszawa
Poland	Research Site	Warszawa
Poland	Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Katedra i Klinika Gastroenterologii i Chorób Przemiany Materii	Warszawa
Poland	Wojskowy Szpital Kliniczny z Poliklinika Oddzial Gastroenterologii	Wroclaw
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	St. Petersburg
South Africa	Kingsbury Hospital	Cape Town
South Africa	Panorama Mediclinic	Cape Town
South Africa	Research Site	Cape Town	Western Cape
South Africa	Parklands Medical Centre	Durban
South Africa	Fordsburg Clinic	Johannesburg
South Africa	Research Site	Port Elizabeth	Eastern Cape
South Africa	Kloof Medi Clinic	Pretoria
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Hospital Universitario del Mar	Barcelona
Spain	Research Site	Cordoba	Andalucia
Spain	Hospital Clínico San Carlos	Madrid
Spain	Research Site	Madrid
Spain	Hospital Universitario Joan XXIII	Tarragona
Sweden	Karolinska University Hospital Solna	Stockholm
Sweden	Sophiahemmet Stockholm	Stockholm
Sweden	Norrlands University Hospital Umea	Umea
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Alizyme

Countries where clinical trial is conducted

Australia,  Belgium,  Czech Republic,  Denmark,  France,  Germany,  Hungary,  Israel,  Italy,  Poland,  Russian Federation,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease activity index		After 4 and 8 weeks of treatment	No
Primary	Cortisol levels		After 4 and 8 weeks of treatment	Yes
Secondary	Simple clinical colitis activity index		8 weeks	No
Secondary	Endoscopy		8 weeks	No
Secondary	Adverse events		12 weeks	Yes
Secondary	Laboratory tests		12 weeks	Yes