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

Alizyme

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Prednisolone; Drug: COLAL-PRED®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00299013

ATL2502/020/CL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 796 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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796 participants in 4 patient groups

1

Active Comparator group

Description:

Prednisolone 40mg oral tablets, once daily, dose tapering weekly (40,40,30,20,15,10,5,0mg) over 8 weeks.

Treatment:

Drug: Prednisolone

2

Experimental group

Description:

COLAL-PRED 40mg oral capsule, once daily for 8 weeks.

Treatment:

Drug: COLAL-PRED®

3

Experimental group

Description:

COLAL-PRED 60mg oral capsule, once daily for 8 weeks.

Treatment:

Drug: COLAL-PRED®

4

Experimental group

Description:

COLAL-PRED 80mg oral capsule, once daily for 8 weeks.

Treatment:

Drug: COLAL-PRED®