Canadian Active & Maintenance Modified Pentasa Study

A multi-centre, randomized, double-blind, non-inferiority trial comparing the efficacy and safety of a new modified oral extended release Pentasa® (mesalamine) 500 mg tablet to the currently marketed Pentasa® (mesalamine) 500 mg tablet in subjects with active mild to moderate ulcerative colitis treated with 4 g/day for 8 weeks and in maintenance of remission of ulcerative colitis in subjects treated with 2 g/day for 24 weeks. The study involves male or non-pregnant female subjects aged 18 to 75 years.

Subjects were randomised on entry into the trial, and if they were in remission at the end of the 8-week Active Phase or the 4-week Run-in Phase, they were eligible for enrolment into the 24-week Maintenance Phase, remaining on the original randomised treatment.

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