Canadian Active & Maintenance Modified Pentasa Study
Condition: Active Ulcerative Colitis; Remission of Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: 5-ASA (5-Aminosalicylate); 5-ASA (5-Aminosalicylate)
Intervention description: 500 mg tablet (modified extended release); 500 mg tablet
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 288.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis; 5-Aminosalicylate

Summary:

      The purpose of this study is to demonstrate that the new modified oral extended-release
      Pentasa® 500mg tablet is at least as efficacious as the currently marketed Pentasa® 500mg
      tablet in active mild to moderate Ulcerative Colitis (UC) and also in maintenance of
      quiescent disease.
    

Eligibility criteria:

        Inclusion Criteria for Active phase:

          -  Newly diagnosed or recurrent, mild to moderate Ulcerative Colitis patients.

          -  Extent of colonic involvement confirmed within the past 36 months

          -  UCDAI score of at least 3 but not greater than 8 and a score of at least 1 for
             endoscopy

          -  Screening tests to rule out any abnormalities in stool, heart or kidney.

          -  Male or non-pregnant females between 18 to 75 years.

          -  Women of childbearing potential to use efficacious contraception as judged by the
             investigator.

          -  Written informed consent given.

        Inclusion Criteria for Maintenance phase:

          -  Newly recruited subjects with documented mild to moderate UC entering the Run-in
             Phase: in clinical remission for at least 1 month and for a maximum of 3 years, and
             receiving 5-ASA 1.4 to 2.5 g/day for maintenance of quiescent disease

          -  Subjects from Active Phase: meeting remission criteria after the 8-week active period

          -  Extent of colonic involvement confirmed within the past 36 months by colonoscopy

          -  In complete remission at entry into the Maintenance Phase, defined as i) a score of 0
             or 1 for stool frequency; ii) a score of 0 for rectal bleeding; iii) a score of 0 for
             endoscopy findings; and iv) a Physician's Global Assessment (PGA) score of 0 or 1

          -  Screening tests to rule out any abnormalities in stool, heart or kidney.

        Exclusion Criteria:

          -  Use of 5-ASA products at a dose >2.5g/day within 7 days prior to entry.

          -  Proctitis, short bowel syndrome, prior bowel surgery, severe UC, other forms of
             Inflammatory Bowel Disease

          -  Infectious diseases, parasites, bacterial pathogens

          -  Allergy to aspirin or salicylate

          -  Liver or kidney abnormalities

          -  Alcohol or drug abuse

          -  Pregnancy

          -  Cancer

          -  Bleeding disorders, ulcers, autoimmune diseases

          -  Mental disorders

          -  Participation in clinical trial in last 30 days

          -  Inability to fill in diary cards / comply with protocol requirements