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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 2, 2006

Last Updated Date

April 24, 2008

Start Date ^ICMJE

March 2006

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Disease activity index
Cortisol levels

Change History

Complete list of historical versions of study NCT00299013 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Simple clinical colitis activity index
Endoscopy
Adverse events
Laboratory tests

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis

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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Ulcerative Colitis

Intervention ^ICMJE

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.

Study Arm (s)

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®

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

796

Completion Date

April 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Poland, Russian Federation, South Africa, Spain, Sweden, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00299013

Other Study ID Numbers ^ICMJE

ATL2502/020/CL

Has Data Monitoring Committee

Responsible Party

Research and Development Director, Alizyme

Study Sponsor ^ICMJE

Alizyme

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Christopher Hawkey

University Hospital, Nottingham

Information Provided By

Alizyme

Verification Date

April 2008

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

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