MedTrace Logo

Canadian Active & Maintenance Modified Pentasa Study

NCT00603733 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2016-04-22

Study results available
· View outcomes & findings →

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.

Conditions

  • Active Ulcerative Colitis
  • Remission of Ulcerative Colitis

Interventions

DRUG

5-ASA (5-Aminosalicylate)

500 mg tablet (modified extended release)

DRUG

5-ASA (5-Aminosalicylate)

500 mg tablet

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Clinical Development Support · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00603733 on ClinicalTrials.gov