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

Last updated: April 24, 2008
Sponsor: Alizyme
Overall Status: Completed

Phase

3

Condition

Colic

Ulcers

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT00299013
ATL2502/020/CL
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Endoscopically confirmed diagnosis of ulcerative colitis

  • Score of 6-10 on the Disease Activity Index (DAI)

  • Moderate to severe mucosal appearance

Exclusion

Exclusion Criteria:

  • Previous colonic surgery

  • Other treatments for ulcerative colitis that have not been stabilised

  • Clinically significant diabetes, heart failure, unstable angina, cirrhosis, renalfailure

  • History of tuberculosis

Study Design

Total Participants: 796
Study Start date:
March 01, 2006
Estimated Completion Date:
April 30, 2008

Study 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.

Connect with a study center

  • Research Site

    Bankstown, New South Wales 2200
    Australia

    Site Not Available

  • Research Site

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Research Site

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Research Site

    Bruxelles, 1070
    Belgium

    Site Not Available

  • Research Site

    Gent, 9000
    Belgium

    Site Not Available

  • Research Site

    Roeselare, 8800
    Belgium

    Site Not Available

  • Gastroenterologicka ambulance

    Hradec Kralove,
    Czech Republic

    Site Not Available

  • Hepato-Gastroenterologie HK s.r.o.

    Hradec Kralove,
    Czech Republic

    Site Not Available

  • Krajska nemocnice Liberec

    Liberec,
    Czech Republic

    Site Not Available

  • Research Site

    Olomouc, 77520
    Czech Republic

    Site Not Available

  • Privatni odborna ambulance

    Prague,
    Czech Republic

    Site Not Available

  • Research Site

    Praha 10, 100 34
    Czech Republic

    Site Not Available

  • Oblastni nemocnice Pribram a.s.

    Pribram,
    Czech Republic

    Site Not Available

  • Okresni nemocnice Tabor

    Tabor,
    Czech Republic

    Site Not Available

  • Nemocnice v Usti nad Orlici

    Usti nad Orlici,
    Czech Republic

    Site Not Available

  • Krajska nemocnice T Bati a s

    Zlin,
    Czech Republic

    Site Not Available

  • Research Site

    Zlin, 762 75
    Czech Republic

    Site Not Available

  • Aalborg Hospital

    Aalborg,
    Denmark

    Site Not Available

  • Gentofte Hospital

    Hellerup,
    Denmark

    Site Not Available

  • Helsingors Hospital

    Helsingor,
    Denmark

    Site Not Available

  • Hvidovre Hospital

    Hvidovre,
    Denmark

    Site Not Available

  • CHU Nord Hepato-Gastroenterologie

    Amiens,
    France

    Site Not Available

  • Hopital de l'Archet II

    Nice,
    France

    Site Not Available

  • Hopital Saint Louis

    Paris,
    France

    Site Not Available

  • Hospital Haut Leveque

    Pessac,
    France

    Site Not Available

  • Am Wallgraben 99

    Stuttgart,
    Germany

    Site Not Available

  • Research Site

    Debrecen, H-4012
    Hungary

    Site Not Available

  • Research Site

    Dunaujvaros, H-2400
    Hungary

    Site Not Available

  • Research Site

    Eger, H-3300
    Hungary

    Site Not Available

  • Petz Aladar Megyei Korhaz

    Gyor,
    Hungary

    Site Not Available

  • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza

    Gyula,
    Hungary

    Site Not Available

  • Research Site

    Hatvan, H-3000
    Hungary

    Site Not Available

  • Miskolc MJV Semmelweis Korhaz

    Miskolc,
    Hungary

    Site Not Available

  • Research Site

    Szekszard, H-7100
    Hungary

    Site Not Available

  • Vas Megyei Markusovszky Korhaz

    Szombathely,
    Hungary

    Site Not Available

  • Fejer Megyei Szent Gyorgy Korhaz

    Székesfehérvár,
    Hungary

    Site Not Available

  • Fejer Megyei Szent Gyorgy Korhaz

    Székesfehérvár,
    Hungary

    Site Not Available

  • Research Site

    Vac, H-2601
    Hungary

    Site Not Available

  • Research Site

    Haifa, 31096
    Israel

    Site Not Available

  • Research Site

    Jerusalem, 91031
    Israel

    Site Not Available

  • Research Site

    Kfar Saba, 44281
    Israel

    Site Not Available

  • Research Site

    Petah-Tikva,
    Israel

    Site Not Available

  • Research Site

    Rehovot, 76100
    Israel

    Site Not Available

  • Research Site

    Tel-Aviv,
    Israel

    Site Not Available

  • Policlinico S. Orsola-Malpighi

    Bologna,
    Italy

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny, Klinika Gastroenterologii i Chorob Wewnetrznych

    Bialystok,
    Poland

    Site Not Available

  • SP ZOZ Uniwersytecki Szpital Kliniczny Nr 5 im. gen. dyw. Boleslawa Szareckiego Uniwersytetu Medycznego w Lodzi Oddział Gastroenterologii i Chorob Wewnetrznych

    Lodz,
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Klinika Gastroenterologii

    Lublin,
    Poland

    Site Not Available

  • Szpital Kolejowy w Pruszkowie Oddzial Wewnetrzny

    Pruszkow,
    Poland

    Site Not Available

  • SPSK Nr 1 im. Prof. Tadeusza Sokolowskiego Pomorskiej Akademii Medycznej Klinika Gastroenterologii i Chorob Wewnetrznych

    Szczecin,
    Poland

    Site Not Available

  • Research Site

    Torun, 87-100
    Poland

    Site Not Available

  • Centrum Onkologii-Instytutu im. Marii Skłodowskiej-Curie Klinika Gastroenterologii

    Warszawa,
    Poland

    Site Not Available

  • Research Site

    Warszawa, 03-563
    Poland

    Site Not Available

  • Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Katedra i Klinika Gastroenterologii i Chorób Przemiany Materii

    Warszawa,
    Poland

    Site Not Available

  • Wojskowy Szpital Kliniczny z Poliklinika Oddzial Gastroenterologii

    Wroclaw,
    Poland

    Site Not Available

  • Research Site

    Moscow, 105203
    Russian Federation

    Site Not Available

  • Research Site

    St. Petersburg, 195067
    Russian Federation

    Site Not Available

  • Research Site

    Port Elizabeth, Eastern Cape 6057
    South Africa

    Site Not Available

  • Research Site

    Cape Town, Western Cape
    South Africa

    Site Not Available

  • Kingsbury Hospital

    Cape Town,
    South Africa

    Site Not Available

  • Panorama Mediclinic

    Cape Town,
    South Africa

    Site Not Available

  • Parklands Medical Centre

    Durban,
    South Africa

    Site Not Available

  • Fordsburg Clinic

    Johannesburg,
    South Africa

    Site Not Available

  • Kloof Medi Clinic

    Pretoria,
    South Africa

    Site Not Available

  • Research Site

    Cordoba, Andalucia 14004
    Spain

    Site Not Available

  • Hospital Clinic i Provincial de Barcelona

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitario del Mar

    Barcelona,
    Spain

    Site Not Available

  • Hospital Clínico San Carlos

    Madrid,
    Spain

    Site Not Available

  • Research Site

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario Joan XXIII

    Tarragona,
    Spain

    Site Not Available

  • Karolinska University Hospital Solna

    Stockholm,
    Sweden

    Site Not Available

  • Sophiahemmet Stockholm

    Stockholm,
    Sweden

    Site Not Available

  • Norrlands University Hospital Umea

    Umea,
    Sweden

    Site Not Available

  • Addenbrooke's Hospital

    Cambridge,
    United Kingdom

    Site Not Available

  • Research Site

    Cottingham, HU16 5JQ
    United Kingdom

    Site Not Available

  • Darent Valley Hospital

    Dartford,
    United Kingdom

    Site Not Available

  • Research Site

    Edinburgh, EH16 4SA
    United Kingdom

    Site Not Available

  • Western General Hospital

    Edinburgh,
    United Kingdom

    Site Not Available

  • Leeds General Infirmary

    Leeds,
    United Kingdom

    Site Not Available

  • Leicester General Hospital

    Leicester,
    United Kingdom

    Site Not Available

  • Research Site

    Liverpool, L7 8XP
    United Kingdom

    Site Not Available

  • Hammersmith Hospital

    London,
    United Kingdom

    Site Not Available

  • Middlesex Hospital

    London,
    United Kingdom

    Site Not Available

  • Royal Victoria Infirmary

    Newcastle upon Tyne,
    United Kingdom

    Site Not Available

  • University Hospital

    Nottingham,
    United Kingdom

    Site Not Available

  • Hope Hospital

    Salford,
    United Kingdom

    Site Not Available

  • Research Site

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

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