Clinical trial NCT00603733: Canadian Active & Maintenance Modified Pentasa Study
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Active Ulcerative Colitis
Remission of Ulcerative Colitis
Keywords: Ulcerative Colitis
5-Aminosalicylate
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-01-29
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Active Phase: Proportion of Active Subjects Achieving Overall Improvement
timeFrame: From baseline to week 8
measure: Maintenance Phase: Proportion of Subjects Experiencing Relapse
timeFrame: Up to week 24
Secondary outcomes:
measure: Frequency of Adverse Events
timeFrame: From baseline to week 24
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary, Faculty of Medicine
state: Alberta
city: Edmonton
country: Canada
facility: Castledowns Medicentre
state: Alberta
city: Brandon
country: Canada
facility: Investigational site
state: Manitoba
city: Saint John
country: Canada
facility: Hilyard Place Building A
state: New Brunswick
city: Barrie
country: Canada
facility: Barrie GI Associates
state: Ontario
city: Guelph
country: Canada
facility: Investigational site
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Oshawa
country: Canada
facility: Investigational site
state: Ontario
city: Ottawa
country: Canada
facility: Investigational site - Phenix Building
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Richmond Hill
country: Canada
facility: Digestive Health Clinic
state: Ontario
city: Sarnia
country: Canada
facility: Investigational site
state: Ontario
city: Sudbury
country: Canada
facility: Investigational site
state: Ontario
city: Thunder Bay
country: Canada
facility: Investigational site
state: Ontario
city: Toronto
country: Canada
facility: JJ Dig Research Ltd
state: Ontario
city: Toronto
country: Canada
facility: Keele Medical Place
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Digestive Disease Association (TDDA)
state: Ontario
city: Windsor
country: Canada
facility: Hotel Dieu Grace Hospital
state: Ontario
city: Windsor
country: Canada
facility: Investigational site
state: Ontario
city: Woodstock
country: Canada
facility: Investigational site
state: Ontario
city: Levis
country: Canada
facility: Hotel Dieu de Levis
state: Quebec
city: Loretteville
country: Canada
facility: Alpha Recherche Clinique Inc.
state: Quebec
city: Montreal
country: Canada
facility: Hopital Maissonneuve Rosemont
state: Quebec
city: Montreal
country: Canada
facility: MUHC-Royal Victoria Hospital
state: Quebec
city: Quebec
country: Canada
facility: Gastro Centre Hospitalier Universitaire de Québec/St-François-d'Assise Hospital
city: Quebec
country: Canada
facility: L'Hotel Dieu de Quebec
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: