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

This study has been completed.
Sponsor:
Information provided by:
Alizyme
ClinicalTrials.gov Identifier:
NCT00299013
First received: March 2, 2006
Last updated: April 24, 2008
Last verified: April 2008

March 2, 2006
April 24, 2008
March 2006
April 2008   (final data collection date for primary outcome measure)
  • Disease activity index [ Time Frame: After 4 and 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Cortisol levels [ Time Frame: After 4 and 8 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Disease activity index
  • Cortisol levels
Complete list of historical versions of study NCT00299013 on ClinicalTrials.gov Archive Site
  • Simple clinical colitis activity index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Endoscopy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Laboratory tests [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Simple clinical colitis activity index
  • Endoscopy
  • Adverse events
  • Laboratory tests
Not Provided
Not Provided
 
Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis
A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ulcerative Colitis
  • Drug: COLAL-PRED®
    COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.
    Other Name: Prednisolone sodium metasulfobenzoate.
  • Drug: Prednisolone
    Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
  • Active Comparator: 1
    Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
    Intervention: Drug: Prednisolone
  • Experimental: 2
    COLAL-PRED 40mg oral capsule, once daily for 8 weeks.
    Intervention: Drug: COLAL-PRED®
  • Experimental: 3
    COLAL-PRED 60mg oral capsule, once daily for 8 weeks.
    Intervention: Drug: COLAL-PRED®
  • Experimental: 4
    COLAL-PRED 80mg oral capsule, once daily for 8 weeks.
    Intervention: Drug: COLAL-PRED®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
796
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   United Kingdom,   Germany,   Hungary,   Poland,   France,   South Africa,   Czech Republic,   Spain,   Sweden,   Italy,   Israel,   Australia,   Belgium,   Russian Federation
 
NCT00299013
ATL2502/020/CL
No
Research and Development Director, Alizyme
Alizyme
Not Provided
Principal Investigator: Christopher Hawkey University Hospital, Nottingham
Alizyme
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP