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

Condition(s) targeted: Ulcerative Colitis

Intervention: COLAL-PRED® (Drug); Prednisolone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Alizyme

Official(s) and/or principal investigator(s):
Christopher Hawkey, Principal Investigator, Affiliation: University Hospital, Nottingham

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.

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Disease activity index

Cortisol levels

Secondary outcome:

Simple clinical colitis activity index

Endoscopy

Adverse events

Laboratory tests

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

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

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

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

Research Site, Cordoba, Andalucia 14004, Spain

Research Site, Port Elizabeth, Eastern Cape 6057, South Africa

Research Site, Bankstown, New South Wales 2200, Australia

Research Site, Bedford Park, South Australia 5042, Australia

Research Site, Parkville, Victoria 3050, Australia

Research Site, Cape Town, Western Cape, South Africa

Starting date: March 2006
Ending date: April 2008
Last updated: April 24, 2008