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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Drug: mesalazine
  • 2.4 g/day QD
• Drug: mesalazine
  • ASACOL 1.6g/day administered BID

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Endoscopic remission at 6 months
  • Time Frame: 6 Months
    Safety Issue?: No

Secondary Measures

• Time to endoscopic relapse
  • Time Frame: 6 Months
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: 6 Months
    Safety Issue?: Yes
• QoL Assessment (Subset of patients)
  • Time Frame: 6 Months
    Safety Issue?: No
• Endoscopic remission with no or mild symptoms
  • Time Frame: 6 Months
    Safety Issue?: No

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

Lead Sponsor: Shire Pharmaceutical Development

Overall Clinical Trial Officials and Contacts

William J Sandborn, MD Principal Investigator Mayo Clinic  

Overall Contact: Shire Call Center +1 866 842 5335 

Information obtained from ClinicalTrials.gov on October 10, 2008

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