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Canadian Active & Maintenance Modified Pentasa Study (CAMMP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00603733
First received: January 16, 2008
Last updated: November 10, 2014
Last verified: November 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Active phase: Proportion of active subjects achieving overall improvement [ Time Frame: From baseline to week 8 ] [ Designated as safety issue: No ]

    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.


  • Maintenance phase: Proportion of subjects experiencing relapse [ Time Frame: Up to week 24 ] [ Designated as safety issue: No ]
    Relapse is defined as a UCDAI score of at least 3 and a score of at least 1 for endoscopy


Secondary Outcome Measures:
  • Active phase: Frequency and severity of adverse events [ Time Frame: From baseline to week 8 ] [ Designated as safety issue: No ]
  • Maintenance phase: Frequency and severity of adverse events [ Time Frame: Up to week 24 ] [ Designated as safety issue: No ]

Enrollment: 343
Study Start Date: October 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 endoscopy
  • 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 investigator
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603733

Locations
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
Investigational site
Windsor, Ontario, Canada
Hotel Dieu Grace Hospital
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
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
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00603733     History of Changes
Other Study ID Numbers: CLN 35.3.11
Study First Received: January 16, 2008
Last Updated: November 10, 2014
Health Authority: Canada: Health Canada

Keywords provided by Ferring Pharmaceuticals:
Ulcerative Colitis
5-Aminosalicylate

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

ClinicalTrials.gov processed this record on November 25, 2014