Canadian Active & Maintenance Modified Pentasa Study (CAMMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00603733
Recruitment Status : Completed
First Posted : January 29, 2008
Results First Posted : April 22, 2016
Last Update Posted : April 22, 2016
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Active Ulcerative Colitis Remission of Ulcerative Colitis Drug: 5-ASA (5-Aminosalicylate) Phase 3

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  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2007
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

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:
  • Pentasa®
  • mesalamine

Active Comparator: Pentasa®
5-ASA (5-Aminosalicylate)
Drug: 5-ASA (5-Aminosalicylate)
500 mg tablet
Other Names:
  • Pentasa®
  • mesalamine

Primary Outcome Measures :
  1. Active Phase: Proportion of Active Subjects Achieving Overall Improvement [ Time Frame: From baseline to week 8 ]

    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.

  2. Maintenance Phase: Proportion of Subjects Experiencing Relapse [ Time Frame: Up to week 24 ]
    Relapse is defined as a UCDAI score of at least 3 and a score of at least 1 for endoscopy

Secondary Outcome Measures :
  1. Frequency of Adverse Events [ Time Frame: From baseline to week 24 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00603733

Canada, Alberta
University of Calgary, Faculty of Medicine
Calgary, Alberta, Canada
Castledowns Medicentre
Edmonton, Alberta, Canada
Canada, Manitoba
Investigational site
Brandon, Manitoba, Canada
Canada, New Brunswick
Hilyard Place Building A
Saint John, New Brunswick, Canada
Canada, Ontario
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
Canada, Quebec
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
Gastro Centre Hospitalier Universitaire de Québec/St-François-d'Assise Hospital
Quebec, Canada
L'Hotel Dieu de Quebec
Quebec, Canada
Sponsors and Collaborators
Ferring Pharmaceuticals
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals Identifier: NCT00603733     History of Changes
Other Study ID Numbers: CLN 35.3.11
First Posted: January 29, 2008    Key Record Dates
Results First Posted: April 22, 2016
Last Update Posted: April 22, 2016
Last Verified: April 2016

Keywords provided by Ferring Pharmaceuticals:
Ulcerative Colitis

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents