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
1 other identifier
interventional
288
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2007
Typical duration for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 16, 2008
CompletedFirst Posted
Study publicly available on registry
January 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
April 22, 2016
CompletedApril 22, 2016
April 1, 2016
3.6 years
January 16, 2008
March 4, 2015
April 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Frequency of Adverse Events
From baseline to week 24
Study Arms (2)
Pentasa® modified extended release
EXPERIMENTAL5-ASA (5-Aminosalicylate)
Pentasa®
ACTIVE COMPARATOR5-ASA (5-Aminosalicylate)
Interventions
500 mg tablet (modified extended release)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study was amended to modify sample size as subject enrolment was lower than anticipated. A data lock was imposed, pending completion of the Maintenance Phase by 12 subjects to report all Active Phase efficacy data \& all available safety data.
Results Point of Contact
- Title
- Clinical Development Support
- Organization
- Ferring Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2008
First Posted
January 29, 2008
Study Start
October 1, 2007
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
April 22, 2016
Results First Posted
April 22, 2016
Record last verified: 2016-04