Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis

Verified by: Shire Pharmaceutical Development, June 2011
First Received: September 7, 2005 | Last Updated: June 6, 2011 | Phase: Phase 3 | Start Date: April 2005
Overall Status: Completed | Estimated Enrollment: 829
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Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug...

Brief Summary

Official Title: “A Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With Asacol 1.6g/Day Twice Daily in the Maintenance of Remission in Patients With Ulcerative Colitis”

Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis.

Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: September 2009

Intervention(s) in this Clinical Trial

  • Drug: SPD476
    • 2.4 g/day Once Daily (QD)
  • Drug: Asacol
    • 1.6g/day administered 800 mg Twice Daily (BID)

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: SPD476
    • Mesalazine
  • Active Comparator: Asacol

Outcome Measures for this Clinical Trial

Primary Measures

  • Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months
    • Time Frame: 6 Months
      Safety Issue?: No

Secondary Measures

  • Withdrawal Due to Relapse of UC
    • Time Frame: Over 6 Months
      Safety Issue?: No
  • Endoscopic Remission of UC With No or Mild Symptoms at 6 Months
    • Time Frame: 6 Months
      Safety Issue?: No
  • Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months
    • Time Frame: Baseline and 6 months
      Safety Issue?: No
  • Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score
    • Time Frame: 6 Months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • previous diagnosis of ulcerative colitis confirmed by histology that has been considered to be in remission for => 30 days
  • female subjects must be post-menopausal, surgically or biologically sterile, or with a negative urine pregnancy test at screening and on adequate contraception

Exclusion Criteria:

  • proctitis
  • previous resective colonic surgery
  • Crohn's disease
  • hypersensitivity to salicylates
  • moderate/severe renal impairment

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Shire Pharmaceutical Development Industry

Overall Clinical Trial Officials and Contacts

William J Sandborn, MD Principal Investigator Mayo Clinic  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00151892

Study ID Number: SPD476-304

ClinicalTrials.gov Identifier: NCT00151892

Health Authority: United States: Food and Drug Administration

FDA recall information

FDA Medical Product Safety Alerts

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