Canadian Active & Maintenance Modified Pentasa Study

NCT ID: NCT00603733

Last Updated: 2016-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-05-31

Brief 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.

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.

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.

Conditions

Active Ulcerative Colitis; Remission of Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pentasa® modified extended release

5-ASA (5-Aminosalicylate)

Group Type: EXPERIMENTAL

5-ASA (5-Aminosalicylate)

Intervention Type: DRUG

500 mg tablet (modified extended release)

Pentasa®

5-ASA (5-Aminosalicylate)

Group Type: ACTIVE_COMPARATOR

5-ASA (5-Aminosalicylate)

Intervention Type: DRUG

500 mg tablet

Interventions

5-ASA (5-Aminosalicylate)

500 mg tablet (modified extended release)

Intervention Type: DRUG

5-ASA (5-Aminosalicylate)

500 mg tablet

Intervention Type: DRUG

Other Intervention Names

Pentasa®; mesalamine; Pentasa®; mesalamine

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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

Greater Sudbury, 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

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

Lévis, Quebec, Canada

Alpha Recherche Clinique Inc.

Loretteville, Quebec, Canada

Hopital Maissonneuve Rosemont

Montreal, Quebec, Canada

MUHC-Royal Victoria Hospital

Montreal, Quebec, Canada

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

Québec, Quebec, Canada

L'Hotel Dieu de Quebec

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

CLN 35.3.11

Identifier Type: -

Identifier Source: org_study_id