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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00299013

Enrollment

796

Registered

2006-03-06

Start date

2006-03-31

Completion date

2008-04-30

Last updated

2008-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

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.

Interventions

DRUGCOLAL-PRED®

COLAL-PRED 40, 60 or 80mg oral capsule, once daily for 8 weeks.

DRUGPrednisolone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Disease activity index	After 4 and 8 weeks of treatment
Cortisol levels	After 4 and 8 weeks of treatment

Secondary

Measure	Time frame
Simple clinical colitis activity index	8 weeks
Endoscopy	8 weeks
Adverse events	12 weeks
Laboratory tests	12 weeks

Countries

Australia, Belgium, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Poland, Russia, South Africa, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026