Canadian Active & Maintenance Modified Pentasa Study

Active Ulcerative Colitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603733
• Other study ID #: CLN 35.3.11
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2008
• Last updated: November 10, 2014
• Start date: October 2007
• Est. completion date: May 2011

Study information

• Verified date: November 2014
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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 and also in maintenance of quiescent disease.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Active Ulcerative Colitis
• Colitis
• Colitis, Ulcerative
• Remission of Ulcerative Colitis
• Ulcer

Intervention

Drug:
• 5-ASA (5-Aminosalicylate)
500 mg tablet (modified extended release)
• 5-ASA (5-Aminosalicylate)
500 mg tablet

Locations

Country	Name	City	State
Canada	Barrie GI Associates	Barrie	Ontario
Canada	Investigational site	Brandon	Manitoba
Canada	University of Calgary, Faculty of Medicine	Calgary	Alberta
Canada	Castledowns Medicentre	Edmonton	Alberta
Canada	Investigational site	Guelph	Ontario
Canada	St. Joseph's Healthcare	Hamilton	Ontario
Canada	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	Investigational site	Oshawa	Ontario
Canada	Investigational site - Phenix Building	Ottawa	Ontario
Canada	Ottawa General Hospital	Ottawa	Ontario
Canada	Gastro Centre Hospitalier Universitaire de Québec/St-François-d'Assise Hospital	Quebec
Canada	L'Hotel Dieu de Quebec	Quebec
Canada	Digestive Health Clinic	Richmond Hill	Ontario
Canada	Hilyard Place Building A	Saint John	New Brunswick
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	Hotel Dieu Grace Hospital	Windsor	Ontario
Canada	Investigational site	Windsor	Ontario
Canada	Investigational site	Woodstock	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to week 8	No
Primary	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	Up to week 24	No
Secondary	Active phase: Frequency and severity of adverse events		From baseline to week 8	No
Secondary	Maintenance phase: Frequency and severity of adverse events		Up to week 24	No