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

Sponsor:	Alizyme
Information provided by:	Alizyme
ClinicalTrials.gov Identifier:	NCT00299013

Purpose

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	Intervention	Phase
Ulcerative Colitis	Drug: COLAL-PRED® Drug: Prednisolone	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate 16-Methyleneprednisolone Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by Alizyme:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	796
Study Start Date:	March 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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 Name: Prednisolone sodium metasulfobenzoate.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299013

Show 86 Study Locations

Sponsors and Collaborators

Alizyme

Investigators

Principal Investigator:

Christopher Hawkey

University Hospital, Nottingham

More Information

No publications provided

Responsible Party:	Research and Development Director, Alizyme
ClinicalTrials.gov Identifier:	NCT00299013 History of Changes
Other Study ID Numbers:	ATL2502/020/CL
Study First Received:	March 2, 2006
Last Updated:	April 24, 2008
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Alizyme:

Ulcerative colitis

Additional relevant MeSH terms:

Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate

Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012