Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476

Last updated: June 8, 2021
Sponsor: Shire
Overall Status: Completed

Phase

2

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT00545389
SPD476-202
  • Ages > 18
  • All Genders

Study Summary

Evaluate the percentage of subjects in remission at the end of an 8-week treatment period for three dose groups (SPD476 1.2 g/day, 2.4 g/day or 4.8 g/day, administered once daily).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • male & female subjects greater than or equal to 18 years of age with newly diagnosedor relapsing mild to moderate ulcerative colitis
  • general medical assessment satisfactory and no clinically significant and relevantabnormalities

Exclusion

Exclusion Criteria:

  • severe ulcerative colitis
  • subject in relapse for > 6 weeks
  • use of systemic or rectal steroids within last 4 weeks prior to baseline
  • subjects with proctitis, previous colonic surgery, Crohn's disease, bleedingdisorders, active ulcer disease
  • subjects hypersensitive to salicylates/aspirin
  • subjects with moderate or severe renal impairment

Study Design

Total Participants: 38
Study Start date:
February 10, 2003
Estimated Completion Date:
October 20, 2004

Connect with a study center

  • Imelda General Hospital

    Bonheiden,
    Belgium

    Site Not Available

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