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Canadian Active & Maintenance Modified Pentasa Study (CAMMP)

Primary Purpose

Active Ulcerative Colitis, Remission of Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
5-ASA (5-Aminosalicylate)
5-ASA (5-Aminosalicylate)
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Active Ulcerative Colitis focused on measuring Ulcerative Colitis, 5-Aminosalicylate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Calgary, Faculty of Medicine
  • Castledowns Medicentre
  • Investigational site
  • Hilyard Place Building A
  • Barrie GI Associates
  • Investigational site
  • St. Joseph's Healthcare
  • Investigational site
  • Investigational site - Phenix Building
  • Ottawa General Hospital
  • Digestive Health Clinic
  • Investigational site
  • Investigational site
  • Investigational site
  • JJ Dig Research Ltd
  • Keele Medical Place
  • St. Michael's Hospital
  • Toronto Digestive Disease Association (TDDA)
  • Hotel Dieu Grace Hospital
  • Investigational site
  • Investigational site
  • Hotel Dieu de Levis
  • Alpha Recherche Clinique Inc.
  • Hopital Maissonneuve Rosemont
  • MUHC-Royal Victoria Hospital
  • Gastro Centre Hospitalier Universitaire de Québec/St-François-d'Assise Hospital
  • L'Hotel Dieu de Quebec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pentasa® modified extended release

Pentasa®

Arm Description

5-ASA (5-Aminosalicylate)

5-ASA (5-Aminosalicylate)

Outcomes

Primary Outcome Measures

Active Phase: Proportion of Active Subjects Achieving Overall Improvement
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
Relapse is defined as a UCDAI score of at least 3 and a score of at least 1 for endoscopy

Secondary Outcome Measures

Frequency of Adverse Events
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.

Full Information

First Posted
January 16, 2008
Last Updated
April 21, 2016
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00603733
Brief Title
Canadian Active & Maintenance Modified Pentasa Study
Acronym
CAMMP
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 Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Ulcerative Colitis, Remission of Ulcerative Colitis
Keywords
Ulcerative Colitis, 5-Aminosalicylate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
288 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pentasa® modified extended release
Arm Type
Experimental
Arm Description
5-ASA (5-Aminosalicylate)
Arm Title
Pentasa®
Arm Type
Active Comparator
Arm Description
5-ASA (5-Aminosalicylate)
Intervention Type
Drug
Intervention Name(s)
5-ASA (5-Aminosalicylate)
Other Intervention Name(s)
Pentasa®, mesalamine
Intervention Description
500 mg tablet (modified extended release)
Intervention Type
Drug
Intervention Name(s)
5-ASA (5-Aminosalicylate)
Other Intervention Name(s)
Pentasa®, mesalamine
Intervention Description
500 mg tablet
Primary Outcome Measure Information:
Title
Active Phase: Proportion of Active Subjects Achieving Overall Improvement
Description
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.
Time Frame
From baseline to week 8
Title
Maintenance Phase: Proportion of Subjects Experiencing Relapse
Description
Relapse is defined as a UCDAI score of at least 3 and a score of at least 1 for endoscopy
Time Frame
Up to week 24
Secondary Outcome Measure Information:
Title
Frequency of Adverse Events
Description
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.
Time Frame
From baseline to week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Calgary, Faculty of Medicine
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Castledowns Medicentre
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Investigational site
City
Brandon
State/Province
Manitoba
Country
Canada
Facility Name
Hilyard Place Building A
City
Saint John
State/Province
New Brunswick
Country
Canada
Facility Name
Barrie GI Associates
City
Barrie
State/Province
Ontario
Country
Canada
Facility Name
Investigational site
City
Guelph
State/Province
Ontario
Country
Canada
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Investigational site
City
Oshawa
State/Province
Ontario
Country
Canada
Facility Name
Investigational site - Phenix Building
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Ottawa General Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Digestive Health Clinic
City
Richmond Hill
State/Province
Ontario
Country
Canada
Facility Name
Investigational site
City
Sarnia
State/Province
Ontario
Country
Canada
Facility Name
Investigational site
City
Sudbury
State/Province
Ontario
Country
Canada
Facility Name
Investigational site
City
Thunder Bay
State/Province
Ontario
Country
Canada
Facility Name
JJ Dig Research Ltd
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Keele Medical Place
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto Digestive Disease Association (TDDA)
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Hotel Dieu Grace Hospital
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
Investigational site
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
Investigational site
City
Woodstock
State/Province
Ontario
Country
Canada
Facility Name
Hotel Dieu de Levis
City
Levis
State/Province
Quebec
Country
Canada
Facility Name
Alpha Recherche Clinique Inc.
City
Loretteville
State/Province
Quebec
Country
Canada
Facility Name
Hopital Maissonneuve Rosemont
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
MUHC-Royal Victoria Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Gastro Centre Hospitalier Universitaire de Québec/St-François-d'Assise Hospital
City
Quebec
Country
Canada
Facility Name
L'Hotel Dieu de Quebec
City
Quebec
Country
Canada

12. IPD Sharing Statement

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Canadian Active & Maintenance Modified Pentasa Study

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