Canadian Active & Maintenance Modified Pentasa Study (CAMMP)

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

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.

Study Overview

• Status: Completed
• Conditions: Active Ulcerative Colitis; Remission of Ulcerative Colitis
• Intervention / Treatment: Drug: 5-ASA (5-Aminosalicylate); Drug: 5-ASA (5-Aminosalicylate)

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.

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada
    • Gastro Centre Hospitalier Universitaire de Québec/St-François-d'Assise Hospital
  • Quebec, Canada
    • L'Hotel Dieu de Quebec
  • Alberta
    • Calgary, Alberta, Canada
      • University of Calgary, Faculty of Medicine
    • Edmonton, Alberta, Canada
      • Castledowns Medicentre
  • Manitoba
    • Brandon, Manitoba, Canada
      • Investigational Site
  • New Brunswick
    • Saint John, New Brunswick, Canada
      • Hilyard Place Building A
  • Ontario
    • Barrie, Ontario, Canada
      • Barrie GI Associates
    • Guelph, Ontario, Canada
      • Investigational Site
    • Hamilton, Ontario, Canada
      • St. Joseph's Healthcare
    • Oshawa, Ontario, Canada
      • Investigational Site
    • Ottawa, Ontario, Canada
      • Ottawa General Hospital
    • Ottawa, Ontario, Canada
      • Investigational site - Phenix Building
    • Richmond Hill, Ontario, Canada
      • Digestive Health Clinic
    • Sarnia, Ontario, Canada
      • Investigational Site
    • Sudbury, Ontario, Canada
      • Investigational Site
    • Thunder Bay, Ontario, Canada
      • Investigational Site
    • Toronto, Ontario, Canada
      • St. Michael's Hospital
    • Toronto, Ontario, Canada
      • JJ Dig Research Ltd
    • Toronto, Ontario, Canada
      • Keele Medical Place
    • Toronto, Ontario, Canada
      • Toronto Digestive Disease Association (TDDA)
    • Windsor, Ontario, Canada
      • Hotel Dieu Grace Hospital
    • Windsor, Ontario, Canada
      • Investigational Site
    • Woodstock, Ontario, Canada
      • Investigational Site
  • Quebec
    • Levis, Quebec, Canada
      • Hotel Dieu de Levis
    • Loretteville, Quebec, Canada
      • Alpha Recherche Clinique Inc.
    • Montreal, Quebec, Canada
      • Hopital Maissonneuve Rosemont
    • Montreal, Quebec, Canada
      • MUHC-Royal Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pentasa® modified extended release; 5-ASA (5-Aminosalicylate)	Drug: 5-ASA (5-Aminosalicylate); 500 mg tablet (modified extended release); Other Names: mesalamine; Pentasa®; Drug: 5-ASA (5-Aminosalicylate); 500 mg tablet; Other Names: mesalamine; Pentasa®
Active Comparator: Pentasa®; 5-ASA (5-Aminosalicylate)	Drug: 5-ASA (5-Aminosalicylate); 500 mg tablet (modified extended release); Other Names: mesalamine; Pentasa®; Drug: 5-ASA (5-Aminosalicylate); 500 mg tablet; Other Names: mesalamine; Pentasa®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active Phase: Proportion of Active Subjects Achieving Overall Improvement	Overall improvement is defined as either a complete remission or a clinical response to therapy as measured by the Ulcerative Colitis Disease Activity Index (UCDAI). Complete remission is 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. A clinical response to therapy in the active disease phase is defined as i) improvement in the baseline PGA score; ii) improvement in endoscopy findings and in at least one other clinical assessment (stool frequency, rectal bleeding); iii) no worsening in any other clinical assessment; iv) a decrease of 2 or more points on the UCDAI score.	From baseline to week 8
Maintenance Phase: Proportion of Subjects Experiencing Relapse	Relapse is defined as a UCDAI score of at least 3 and a score of at least 1 for endoscopy	Up to week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Adverse Events	Safety dataset represents all patients in all study phases exposed to study drug at anytime during study. Safety dataset was a combination of the active, run-in and maintenance phases and therefore it is not possible to report the adverse events per phase.	From baseline to week 24

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: January 16, 2008
• First Submitted That Met QC Criteria: January 28, 2008
• First Posted (Estimate): January 29, 2008

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: April 21, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; 5-Aminosalicylate
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Mesalamine
• Other Study ID Numbers: CLN 35.3.11