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NCT Number: NCT00299013

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Bankstown, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COLAL-PRED®

Drug

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

Other names: Prednisolone sodium metasulfobenzoate.

Prednisolone

Drug

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

Primary outcomes

  1. Disease activity index

    Time frame: After 4 and 8 weeks of treatment

  2. Cortisol levels

    Time frame: After 4 and 8 weeks of treatment

Secondary outcomes

  1. Simple clinical colitis activity index

    Time frame: 8 weeks

  2. Endoscopy

    Time frame: 8 weeks

  3. Adverse events

    Time frame: 12 weeks

  4. Laboratory tests

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Alizyme

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 6, 2006
Registry last updated
Apr 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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