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

Phase 3

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: Prednisolone; Drug: COLAL-PRED®

• Registration Number: NCT00299013
• Lead Sponsor: Alizyme

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 Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-02
• Study First Submitted QC: 2006-03-02
• Study First Posted: 2006-03-06
• Status Verified: 2008-04
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Last Update Submitted: 2008-04-24
• Last Update Posted: 2008-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 796

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Prednisolone	Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.
2	COLAL-PRED®	COLAL-PRED 40mg oral capsule, once daily for 8 weeks.
3	COLAL-PRED®	COLAL-PRED 60mg oral capsule, once daily for 8 weeks.
4	COLAL-PRED®	COLAL-PRED 80mg oral capsule, once daily for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Disease activity index	After 4 and 8 weeks of treatment
Cortisol levels	After 4 and 8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Simple clinical colitis activity index	8 weeks
Endoscopy	8 weeks
Adverse events	12 weeks
Laboratory tests	12 weeks

Trial Locations

Locations (54)

Research Site; 🇬🇧 Sheffield, United Kingdom

Gastroenterologicka ambulance; 🇨🇿 Hradec Kralove, Czech Republic

Hepato-Gastroenterologie HK s.r.o.; 🇨🇿 Hradec Kralove, Czech Republic

Krajska nemocnice Liberec; 🇨🇿 Liberec, Czech Republic

Privatni odborna ambulance; 🇨🇿 Prague, Czech Republic

Oblastni nemocnice Pribram a.s.; 🇨🇿 Pribram, Czech Republic

Okresni nemocnice Tabor; 🇨🇿 Tabor, Czech Republic

Nemocnice v Usti nad Orlici; 🇨🇿 Usti nad Orlici, Czech Republic

Krajska nemocnice T Bati a s; 🇨🇿 Zlin, Czech Republic

Aalborg Hospital; 🇩🇰 Aalborg, Denmark

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