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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00299013




Registration number
NCT00299013
Ethics application status
Date submitted
2/03/2006
Date registered
6/03/2006
Date last updated
25/04/2008

Titles & IDs
Public title
Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis
Scientific 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
Secondary ID [1] 0 0
ATL2502/020/CL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - COLAL-PRED®
Treatment: Drugs - Prednisolone

Active comparator: 1 - 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.

Experimental: 3 - COLAL-PRED 60mg oral capsule, once daily for 8 weeks.

Experimental: 4 - COLAL-PRED 80mg oral capsule, once daily for 8 weeks.


Treatment: Drugs: COLAL-PRED®
COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.

Treatment: Drugs: Prednisolone
Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease activity index
Timepoint [1] 0 0
After 4 and 8 weeks of treatment
Primary outcome [2] 0 0
Cortisol levels
Timepoint [2] 0 0
After 4 and 8 weeks of treatment
Secondary outcome [1] 0 0
Simple clinical colitis activity index
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Endoscopy
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Adverse events
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Laboratory tests
Timepoint [4] 0 0
12 weeks

Eligibility
Key inclusion criteria
* Endoscopically confirmed diagnosis of ulcerative colitis
* Score of 6-10 on the Disease Activity Index (DAI)
* Moderate to severe mucosal appearance
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2008
Sample size
Target
Accrual to date
Final
796
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Bankstown
Recruitment hospital [2] 0 0
Research Site - Bedford Park
Recruitment hospital [3] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Belgium
State/province [2] 0 0
Gent
Country [3] 0 0
Belgium
State/province [3] 0 0
Roeselare
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Hradec Kralove
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Liberec
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Olomouc
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Prague
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Praha 10
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Pribram
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Tabor
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Usti nad Orlici
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Zlin
Country [13] 0 0
Denmark
State/province [13] 0 0
Aalborg
Country [14] 0 0
Denmark
State/province [14] 0 0
Hellerup
Country [15] 0 0
Denmark
State/province [15] 0 0
Helsingor
Country [16] 0 0
Denmark
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Hvidovre
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France
State/province [17] 0 0
Amiens
Country [18] 0 0
France
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Nice
Country [19] 0 0
France
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Paris
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France
State/province [20] 0 0
Pessac
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Germany
State/province [21] 0 0
Stuttgart
Country [22] 0 0
Hungary
State/province [22] 0 0
Debrecen
Country [23] 0 0
Hungary
State/province [23] 0 0
Dunaujvaros
Country [24] 0 0
Hungary
State/province [24] 0 0
Eger
Country [25] 0 0
Hungary
State/province [25] 0 0
Gyor
Country [26] 0 0
Hungary
State/province [26] 0 0
Gyula
Country [27] 0 0
Hungary
State/province [27] 0 0
Hatvan
Country [28] 0 0
Hungary
State/province [28] 0 0
Miskolc
Country [29] 0 0
Hungary
State/province [29] 0 0
Szekszard
Country [30] 0 0
Hungary
State/province [30] 0 0
Szombathely
Country [31] 0 0
Hungary
State/province [31] 0 0
Székesfehérvár
Country [32] 0 0
Hungary
State/province [32] 0 0
Vac
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Israel
State/province [33] 0 0
Haifa
Country [34] 0 0
Israel
State/province [34] 0 0
Jerusalem
Country [35] 0 0
Israel
State/province [35] 0 0
Kfar Saba
Country [36] 0 0
Israel
State/province [36] 0 0
Petah-Tikva
Country [37] 0 0
Israel
State/province [37] 0 0
Rehovot
Country [38] 0 0
Israel
State/province [38] 0 0
Tel-Aviv
Country [39] 0 0
Italy
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Bologna
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Poland
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Bialystok
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Pruszkow
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Poland
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Szczecin
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Poland
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Torun
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Poland
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Warszawa
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Poland
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Wroclaw
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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South Africa
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Eastern Cape
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South Africa
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Western Cape
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South Africa
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Cape Town
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South Africa
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Durban
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South Africa
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Johannesburg
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South Africa
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Pretoria
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Spain
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Andalucia
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Tarragona
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Sweden
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Stockholm
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Sweden
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Umea
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United Kingdom
State/province [62] 0 0
Cambridge
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Cottingham
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Dartford
Country [65] 0 0
United Kingdom
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Edinburgh
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United Kingdom
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Leeds
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United Kingdom
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Leicester
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Nottingham
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Salford
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alizyme
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00299013
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Hawkey
Address 0 0
University Hospital, Nottingham
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00299013