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CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission

NCT00092508 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1725

Last updated 2007-06-21

No results posted yet for this study

Summary

This dose comparison study, taking place at over 200 sites worldwide, will compare the dosing, safety and efficacy of an investigational medicine OPC-6535 to the dosing, safety and efficacy of Asacol ® in the maintenance of remission in subjects with ulcerative colitis.

Conditions

Interventions

DRUG

OPC-6535

DRUG

Asacol®

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-05-31
Completion
2007-05-31

Countries

  • United States

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 NCT00092508 on ClinicalTrials.gov