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Canadian Active & Maintenance Modified Pentasa Study

Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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: Completed

Sponsored by: Ferring Pharmaceuticals

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


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.

Clinical Details

Official title: A Multicentre, Randomised, 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

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

Primary outcome:

Active phase: Proportion of active subjects achieving overall improvement

Maintenance phase: Proportion of subjects experiencing relapse

Secondary outcome:

Active phase: Frequency and severity of adverse events

Maintenance phase: Frequency and severity of adverse events

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.


Inclusion Criteria for Active phase:

- Newly diagnosed or recurrent, mild to moderate Ulcerative Colitis patients who are

flaring or in remission.

- 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


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

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

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

- Normal electrocardiogram at screening, as per investigator judgment

- Calculated creatinine clearance > 80 mL/min (if ≤ 80 mL/min, 24-hour urine collection

for measured creatinine clearance to be performed; if results not within laboratory reference range, subject was to be excluded)

- Males or non-pregnant females aged 18 to 75 years

- Women of childbearing potential to use efficacious contraception as judged by the


- Written informed consent given

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

Locations and Contacts

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

L'Hotel Dieu de Quebec, Quebec, Canada

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

Castledowns Medicentre, Edmonton, Alberta, Canada

Investigational site, Brandon, Manitoba, Canada

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

Barrie GI Associates, Barrie, Ontario, Canada

Investigational site, Guelph, Ontario, Canada

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

Investigational site, Oshawa, Ontario, Canada

Investigational site - Phenix Building, Ottawa, Ontario, Canada

Ottawa General Hospital, Ottawa, Ontario, Canada

Digestive Health Clinic, Richmond Hill, Ontario, Canada

Investigational site, Sarnia, Ontario, Canada

Investigational site, Sudbury, Ontario, Canada

Investigational site, Thunder Bay, Ontario, Canada

JJ Dig Research Ltd, Toronto, Ontario, Canada

Keele Medical Place, Toronto, Ontario, Canada

St. Michael's Hospital, Toronto, Ontario, Canada

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

Hotel Dieu Grace Hospital, Windsor, Ontario, Canada

Investigational site, Windsor, Ontario, Canada

Investigational site, Woodstock, Ontario, Canada

Hotel Dieu de Levis, Levis, Quebec, Canada

Alpha Recherche Clinique Inc., Loretteville, Quebec, Canada

Hopital Maissonneuve Rosemont, Montreal, Quebec, Canada

MUHC-Royal Victoria Hospital, Montreal, Quebec, Canada

Additional Information

Starting date: October 2007
Last updated: November 10, 2014

Page last updated: August 23, 2015

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