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OpenTrials
Completed

NCT Number: NCT00503243

Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis

The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given twice daily ([BID] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in subjects with acute, mild to moderate ulcerative colitis.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • newly diagnosed or diagnosis of relapsing (relapsed <= 6 weeks to baseline) mild to moderate ulcerative colitis
  • women not of childbearing potential or WOCP who agreed to use an effective contraceptive method

Exclusion criteria

  • severe ulcerative colitis or relapsed for > 6 weeks prior to baseline
  • subjects who had relapsed on maintenance therapy with doses of mesalazine > 2.0 g/day
  • subjects with Crohn's disease, proctitis, bleeding disorders or active peptic ulcer disease
  • subjects with asthma if they were known to be mesalazine-sensitive
  • subjects who were at immediate or significant risk of toxic megacolon
  • subjects who had previous resective colonic surgery
  • subjects who had moderate or severe renal impairment

Treatment and study plan

Delayed and extended release mesalazine

Drug

Primary outcomes

  1. Percentage of subjects in remission (Ulcerative Colitis Disease Activity Index score of <= 1, with scores of 0 for rectal bleeding and stool frequency, and a sigmoidoscopy score reduction of 1 point or more from baseline

    Time frame: 8 weeks

Secondary outcomes

  1. Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score

    Time frame: 8 weeks

  2. Change in the UC-DAI score

    Time frame: 8 weeks

  3. Change in symptoms (rectal bleeding and stool frequency)

    Time frame: 2, 4 and 8 weeks

  4. Change in sigmoidoscopic (mucosal) appearance

    Time frame: 8 weeks

  5. Time to withdrawal from the start of study medication

    Time frame: Throughout the study period of 8 weeks

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A Phase III, Randomized, Multi-Centre, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) Versus SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jul 18, 2007
Registry last updated
Jun 11, 2021

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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