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Canadian Active & Maintenance Modified Pentasa Study (CAMMP)

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00603733
First received: January 16, 2008
Last updated: June 29, 2011
Last verified: June 2011
History of Changes
  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)
Official Title: A Safety & Efficacy Study of Pentasa for Mild to Moderate Ulcerative Colitis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • The primary efficacy endpoint is the proportion of active subjects at Week 8 to achieve improvement from baseline and the proportion of maintenance subjects who experience relapse before Week 24. [ Time Frame: 8 weeks for Active Phase & 24 weeks for maintenance phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Endpoints Safety will be compared between the two 5-ASA groups in both the active and the maintenance phase of the study. [ Time Frame: 8 weeks for active & 24 weeks for maintenance phase. ] [ Designated as safety issue: Yes ]

Enrollment: 343
Study Start Date: October 2007
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: 5-ASA (5-Aminosalicylate)
Pentasa (mesalamine) 500mg tablet
Active Comparator: 2 Drug: 5-ASA (5-Aminosalicylate)
Pentasa (mesalamine) 500mg tablet

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:

  • Newly diagnosed or recurrent Ulcerative Colitis patients who are flaring or in remission.
  • Screening tests to rule out any abnormalities in stool, heart or kidney.
  • Male or non-pregnant females between 18 to 75 years.

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
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
Ottawa General Hospital
Ottawa, Ontario, Canada
Investigational site - Phenix Building
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
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto Digestive Disease Association (TDDA)
Toronto, Ontario, Canada
Keele Medical Place
Toronto, Ontario, Canada
JJ Dig Research Ltd
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
Canada
L'Hotel Dieu de Quebec
Quebec, Canada
Gastro Centre Hospitalier Universitaire de Québec/St-François-d'Assise Hospital
Quebec, Canada
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clincial Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00603733     History of Changes
Other Study ID Numbers: FE999907 (PENTASA), CAMMP CLN 35.3.11
Study First Received: January 16, 2008
Last Updated: June 29, 2011
Health Authority: Canada: Health Canada

Keywords provided by Ferring Pharmaceuticals:
Ulcerative Colitis
5-Aminosalicylate

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

ClinicalTrials.gov processed this record on May 23, 2013