Canadian Active & Maintenance Modified Pentasa Study

Condition(s) targeted: Active Ulcerative Colitis; Remission of Ulcerative Colitis

Intervention: 5-ASA (5-Aminosalicylate) (Drug); 5-ASA (5-Aminosalicylate) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals

Overall contact:
Clinical Development Support, Email: DK0-Disclosure@ferring.com

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 and also in maintenance of quiescent disease.

Official title: A Safety & Efficacy Study of Pentasa for Mild to Moderate Ulcerative Colitis Patients

Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: The primary efficacy endpoint is the proportion of active study subjects at Week 8 in the active disease treatment phase in each treatment group to achieve an overall improvement from baseline.

Secondary outcome: Secondary Endpoints Safety will be compared between the two 5-ASA groups in both the active and the maintenance phase of the study.

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Newly diagnosed or recurrent Ulcerative Colitis patients who are flaring or in

remission.

- Screening tests to rule out any abnormalities in stool, heart or kidney.

- Male or non-pregnant females between 18 to 75 years.

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 IBD

- 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

Clinical Development Support, Email: DK0-Disclosure@ferring.com

L'Hotel Dieu de Quebec, Quebec, Canada; Completed

Gastro Centre Hospitalier Universitaire de Québec/St-François-d'Assise Hospital, Quebec, Canada; Recruiting

University of Calgary, Faculty of Medicine, Calgary, Alberta, Canada; Completed

Castledowns Medicentre, Edmonton, Alberta, Canada; Completed

Investigational site, Vancouver, British Columbia, Canada; Withdrawn

Investigational site, Brandon, Manitoba, Canada; Recruiting

Hilyard Place Building A, Saint John, New Brunswick, Canada; Recruiting

Patient Research Centre, St. John's, Newfoundland and Labrador, Canada; Withdrawn

QEII Health Sciences Centre, Halifax, Nova Scotia, Canada; Withdrawn

Barrie GI Associates, Barrie, Ontario, Canada; Completed

Investigational site, Guelph, Ontario, Canada; Completed

St. Joseph's Healthcare, Hamilton, Ontario, Canada; Completed

Investigational site, Oshawa, Ontario, Canada; Recruiting

Ottawa General Hospital, Ottawa, Ontario, Canada; Completed

Investigational site - Phenix Building, Ottawa, Ontario, Canada; Completed

Digestive Health Clinic, Richmond Hill, Ontario, Canada; Recruiting

Investigational site, Sarnia, Ontario, Canada; Recruiting

Scarborough North Meds Arts, Scarborough, Ontario, Canada; Withdrawn

Investigational site, Sudbury, Ontario, Canada; Recruiting

Investigational site, Thunder Bay, Ontario, Canada; Recruiting

St. Michael's Hospital, Toronto, Ontario, Canada; Active, not recruiting

Toronto Digestive Disease Association (TDDA), Toronto, Ontario, Canada; Recruiting

Keele Medical Place, Toronto, Ontario, Canada; Recruiting

JJ Dig Research Ltd, Toronto, Ontario, Canada; Completed

Hotel Dieu Grace Hospital, Windsor, Ontario, Canada; Recruiting

Investigational site, Windsor, Ontario, Canada; Recruiting

Investigational site, Woodstock, Ontario, Canada; Recruiting

Hotel Dieu de Levis, Levis, Quebec, Canada; Completed

Alpha Recherche Clinique Inc., Loretteville, Quebec, Canada; Recruiting

Hopital Maissonneuve Rosemont, Montreal, Quebec, Canada; Recruiting

MUHC-Royal Victoria Hospital, Montreal, Quebec, Canada; Recruiting

Starting date: October 2007
Last updated: August 19, 2010