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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: April 21, 2016
Last verified: April 2016

January 16, 2008
April 21, 2016
October 2007
May 2011   (final data collection date for primary outcome measure)
  • 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
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
Frequency of Adverse Events [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
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.
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 ]
Not Provided
Not Provided
 
Canadian Active & Maintenance Modified Pentasa Study
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
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Active Ulcerative Colitis
  • Remission of Ulcerative Colitis
  • Drug: 5-ASA (5-Aminosalicylate)
    500 mg tablet (modified extended release)
    Other Names:
    • Pentasa®
    • mesalamine
  • Drug: 5-ASA (5-Aminosalicylate)
    500 mg tablet
    Other Names:
    • Pentasa®
    • mesalamine
  • Experimental: Pentasa® modified extended release
    5-ASA (5-Aminosalicylate)
    Intervention: Drug: 5-ASA (5-Aminosalicylate)
  • Active Comparator: Pentasa®
    5-ASA (5-Aminosalicylate)
    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
288
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00603733
CLN 35.3.11
No
Not Provided
Not Provided
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
April 2016

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