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

NCT00299013 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 796

Last updated 2008-04-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

COLAL-PRED®

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

DRUG

Prednisolone

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

Sponsors & Collaborators

  • Alizyme

    lead INDUSTRY

Principal Investigators

  • Christopher Hawkey · University Hospital, Nottingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

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

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00299013 on ClinicalTrials.gov