MedTrace Logo

Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

NCT00209300 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 362

Last updated 2011-05-19

No results posted yet for this study

Summary

This is a multi-centre, randomised, controlled, investigator blinded study. The randomisation will be done centrally. The patients will be treated for 1 year, with clinical and laboratory assessments at 0, 4, 8 and 12 months.

Endoscopic examination is at enrollment and on completion of the study (at relapse or after 12 months).

Number of Subjects (Planned and Analysed):

* 360 patients for demonstration of non-inferiority between once daily and twice daily;
* 326 to be analysed in per-protocol (PP) analyses; and
* 360 in intention-to-treat (ITT) analyses.

Conditions

Interventions

DRUG

Pentasa

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Clinical Development Support · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2007-05-31
Completion
2007-06-30

Countries

  • Belgium
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Netherlands
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT00209300 on ClinicalTrials.gov