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

January 16, 2008
June 29, 2011
October 2007
December 2010   (final data collection date for primary outcome measure)
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 ]
The primary efficacy endpoint is the proportion of active study subjects at Week 8 in the active disease treatment phase in each treatment group to achieve an overall improvement from baseline. [ Time Frame: 8 weeks for Active Phase & 24 weeks for maintenance phase ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00603733 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Canadian Active & Maintenance Modified Pentasa Study
A Safety & Efficacy Study of Pentasa for Mild to Moderate Ulcerative Colitis Patients

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
  • Active Ulcerative Colitis
  • Remission of Ulcerative Colitis
Drug: 5-ASA (5-Aminosalicylate)
Pentasa (mesalamine) 500mg tablet
  • Active Comparator: 1
    Intervention: Drug: 5-ASA (5-Aminosalicylate)
  • Active Comparator: 2
    Intervention: Drug: 5-ASA (5-Aminosalicylate)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
343
June 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00603733
FE999907 (PENTASA), CAMMP CLN 35.3.11
No
Clincial Development Support, Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP