Canadian Active & Maintenance Modified Pentasa Study

Phase 3

Completed

• Conditions: Active Ulcerative Colitis; Remission of Ulcerative Colitis
• Interventions: Drug: 5-ASA (5-Aminosalicylate)

• Registration Number: NCT00603733
• Lead Sponsor: Ferring Pharmaceuticals

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-01-16
• Study First Submitted QC: 2008-01-28
• Study First Posted: 2008-01-29
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2015-03-04
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-21
• Last Update Submitted: 2016-04-21
• Results First Posted: 2016-04-22
• Last Update Posted: 2016-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pentasa® modified extended release	5-ASA (5-Aminosalicylate)	5-ASA (5-Aminosalicylate)
Pentasa®	5-ASA (5-Aminosalicylate)	5-ASA (5-Aminosalicylate)

Primary Outcome Measures

Name	Time	Method
Active Phase: Proportion of Active Subjects Achieving Overall Improvement	From baseline to week 8	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	Up to week 24	Relapse is defined as a UCDAI score of at least 3 and a score of at least 1 for endoscopy

Secondary Outcome Measures

Name	Time	Method
Frequency of Adverse Events	From baseline to week 24	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.

Trial Locations

Locations (20)

Hilyard Place Building A; 🇨🇦 Saint John, New Brunswick, Canada

L'Hotel Dieu de Quebec; 🇨🇦 Quebec, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Hopital Maissonneuve Rosemont; 🇨🇦 Montreal, Quebec, Canada

Castledowns Medicentre; 🇨🇦 Edmonton, Alberta, Canada

University of Calgary, Faculty of Medicine; 🇨🇦 Calgary, Alberta, Canada

Barrie GI Associates; 🇨🇦 Barrie, Ontario, Canada

Investigational site; 🇨🇦 Woodstock, Ontario, Canada

Investigational site - Phenix Building; 🇨🇦 Ottawa, Ontario, Canada

St. Joseph's Healthcare; 🇨🇦 Hamilton, Ontario, Canada

Ottawa General Hospital; 🇨🇦 Ottawa, Ontario, Canada

Digestive Health Clinic; 🇨🇦 Richmond Hill, Ontario, Canada

JJ Dig Research Ltd; 🇨🇦 Toronto, Ontario, Canada

Toronto Digestive Disease Association (TDDA); 🇨🇦 Toronto, Ontario, Canada

Hotel Dieu Grace Hospital; 🇨🇦 Windsor, Ontario, Canada

Hotel Dieu de Levis; 🇨🇦 Levis, Quebec, Canada

Alpha Recherche Clinique Inc.; 🇨🇦 Loretteville, Quebec, Canada

Keele Medical Place; 🇨🇦 Toronto, Ontario, Canada

Gastro Centre Hospitalier Universitaire de Québec/St-François-d'Assise Hospital; 🇨🇦 Quebec, Canada

MUHC-Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada