Overview

Canadian Active & Maintenance Modified Pentasa Study

Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ferring Pharmaceuticals
Treatments:
Mesalamine
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