| 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
|
| |
| 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. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Ulcerative Colitis |
- Drug: COLAL-PRED®
- Drug: Prednisolone
|
- Active Comparator: Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
- Experimental: COLAL-PRED 40mg oral capsule, once daily for 8 weeks.
- Experimental: COLAL-PRED 60mg oral capsule, once daily for 8 weeks.
- Experimental: COLAL-PRED 80mg oral capsule, once daily for 8 weeks.
|
| |
| |
| 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 |
| Australia, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Poland, Russian Federation, South Africa, Spain, Sweden, United Kingdom |
| |
| NCT00299013 |
| Research and Development Director, Alizyme |
| ATL2502/020/CL |
| Alizyme |
|
| Principal Investigator: |
Christopher Hawkey |
University Hospital, Nottingham |
|
|
| Alizyme |
| April 2008 |
