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

Sponsor
Alizyme (Industry)
Overall Status
Completed
CT.gov ID
NCT00299013
Collaborator
(none)
796
Enrollment
86
Locations
4
Arms
25
Duration (Months)
9.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
796 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Apr 1, 2008
Actual Study Completion Date :
Apr 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.

Drug: Prednisolone
Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
Experimental: 2

COLAL-PRED 40mg oral capsule, once daily for 8 weeks.

Drug: COLAL-PRED®
COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
Other Names:
  • Prednisolone sodium metasulfobenzoate.

    		•
    Experimental: 3

    COLAL-PRED 60mg oral capsule, once daily for 8 weeks.

    Drug: COLAL-PRED®
    COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
    Other Names:
  • Prednisolone sodium metasulfobenzoate.

    		•
    Experimental: 4

    COLAL-PRED 80mg oral capsule, once daily for 8 weeks.

    Drug: COLAL-PRED®
    COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
    Other Names:
  • Prednisolone sodium metasulfobenzoate.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Disease activity index [After 4 and 8 weeks of treatment]

    2. Cortisol levels [After 4 and 8 weeks of treatment]

    Secondary Outcome Measures

    1. Simple clinical colitis activity index [8 weeks]

    2. Endoscopy [8 weeks]

    3. Adverse events [12 weeks]

    4. Laboratory tests [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Bankstown New South Wales Australia 2200
    2 Research Site Bedford Park South Australia Australia 5042
    3 Research Site Parkville Victoria Australia 3050
    4 Research Site Bruxelles Belgium 1070
    5 Research Site Gent Belgium 9000
    6 Research Site Roeselare Belgium 8800
    7 Gastroenterologicka ambulance Hradec Kralove Czech Republic
    8 Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czech Republic
    9 Krajska nemocnice Liberec Liberec Czech Republic
    10 Research Site Olomouc Czech Republic 77520
    11 Privatni odborna ambulance Prague Czech Republic
    12 Research Site Praha 10 Czech Republic 100 34
    13 Oblastni nemocnice Pribram a.s. Pribram Czech Republic
    14 Okresni nemocnice Tabor Tabor Czech Republic
    15 Nemocnice v Usti nad Orlici Usti nad Orlici Czech Republic
    16 Research Site Zlin Czech Republic 762 75
    17 Krajska nemocnice T Bati a s Zlin Czech Republic
    18 Aalborg Hospital Aalborg Denmark
    19 Gentofte Hospital Hellerup Denmark
    20 Helsingors Hospital Helsingor Denmark
    21 Hvidovre Hospital Hvidovre Denmark
    22 CHU Nord Hepato-Gastroenterologie Amiens France
    23 Hopital de l'Archet II Nice France
    24 Hopital Saint Louis Paris France
    25 Hospital Haut Leveque Pessac France
    26 Am Wallgraben 99 Stuttgart Germany
    27 Research Site Debrecen Hungary H-4012
    28 Research Site Dunaujvaros Hungary H-2400
    29 Research Site Eger Hungary H-3300
    30 Petz Aladar Megyei Korhaz Gyor Hungary
    31 Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza Gyula Hungary
    32 Research Site Hatvan Hungary H-3000
    33 Miskolc MJV Semmelweis Korhaz Miskolc Hungary
    34 Research Site Szekszard Hungary H-7100
    35 Vas Megyei Markusovszky Korhaz Szombathely Hungary
    36 Fejer Megyei Szent Gyorgy Korhaz Székesfehérvár Hungary
    37 Research Site Vac Hungary H-2601
    38 Research Site Haifa Israel 31096
    39 Research Site Jerusalem Israel 91031
    40 Research Site Kfar Saba Israel 44281
    41 Research Site Petah-Tikva Israel
    42 Research Site Rehovot Israel 76100
    43 Research Site Tel-Aviv Israel
    44 Policlinico S. Orsola-Malpighi Bologna Italy
    45 Samodzielny Publiczny Szpital Kliniczny, Klinika Gastroenterologii i Chorob Wewnetrznych Bialystok Poland
    46 SP ZOZ Uniwersytecki Szpital Kliniczny Nr 5 im. gen. dyw. Boleslawa Szareckiego Uniwersytetu Medycznego w Lodzi Oddział Gastroenterologii i Chorob Wewnetrznych Lodz Poland
    47 Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Klinika Gastroenterologii Lublin Poland
    48 Szpital Kolejowy w Pruszkowie Oddzial Wewnetrzny Pruszkow Poland
    49 SPSK Nr 1 im. Prof. Tadeusza Sokolowskiego Pomorskiej Akademii Medycznej Klinika Gastroenterologii i Chorob Wewnetrznych Szczecin Poland
    50 Research Site Torun Poland 87-100
    51 Research Site Warszawa Poland 03-563
    52 Centrum Onkologii-Instytutu im. Marii Skłodowskiej-Curie Klinika Gastroenterologii Warszawa Poland
    53 Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Katedra i Klinika Gastroenterologii i Chorób Przemiany Materii Warszawa Poland
    54 Wojskowy Szpital Kliniczny z Poliklinika Oddzial Gastroenterologii Wroclaw Poland
    55 Research Site Moscow Russian Federation 105203
    56 Research Site St. Petersburg Russian Federation 195067
    57 Research Site Port Elizabeth Eastern Cape South Africa 6057
    58 Research Site Cape Town Western Cape South Africa
    59 Kingsbury Hospital Cape Town South Africa
    60 Panorama Mediclinic Cape Town South Africa
    61 Parklands Medical Centre Durban South Africa
    62 Fordsburg Clinic Johannesburg South Africa
    63 Kloof Medi Clinic Pretoria South Africa
    64 Research Site Cordoba Andalucia Spain 14004
    65 Hospital Clinic i Provincial de Barcelona Barcelona Spain
    66 Hospital Universitario del Mar Barcelona Spain
    67 Research Site Madrid Spain 28034
    68 Hospital Clínico San Carlos Madrid Spain
    69 Hospital Universitario Joan XXIII Tarragona Spain
    70 Karolinska University Hospital Solna Stockholm Sweden
    71 Sophiahemmet Stockholm Stockholm Sweden
    72 Norrlands University Hospital Umea Umea Sweden
    73 Addenbrooke's Hospital Cambridge United Kingdom
    74 Research Site Cottingham United Kingdom HU16 5JQ
    75 Darent Valley Hospital Dartford United Kingdom
    76 Research Site Edinburgh United Kingdom EH16 4SA
    77 Western General Hospital Edinburgh United Kingdom
    78 Leeds General Infirmary Leeds United Kingdom
    79 Leicester General Hospital Leicester United Kingdom
    80 Research Site Liverpool United Kingdom L7 8XP
    81 Hammersmith Hospital London United Kingdom
    82 Middlesex Hospital London United Kingdom
    83 Royal Victoria Infirmary Newcastle upon Tyne United Kingdom
    84 University Hospital Nottingham United Kingdom
    85 Hope Hospital Salford United Kingdom
    86 Research Site Sheffield United Kingdom S10 2JF

    Sponsors and Collaborators

    • Alizyme

    Investigators

    • Principal Investigator: Christopher Hawkey, University Hospital, Nottingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00299013
    Other Study ID Numbers:
    • ATL2502/020/CL
    First Posted:
    Mar 6, 2006
    Last Update Posted:
    Apr 25, 2008
    Last Verified:
    Apr 1, 2008
    Keywords provided by , ,
    Ulcerative colitis
    Additional relevant MeSH terms:
    Colitis
    Colitis, Ulcerative
    Ulcer
    Prednisolone
    Methylprednisolone Acetate
    Methylprednisolone
    Methylprednisolone Hemisuccinate
    Prednisolone acetate
    Prednisolone hemisuccinate
    Prednisolone phosphate

    Study Results

    No Results Posted as of Apr 25, 2008