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FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis

NCT00064454 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2012-05-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of the drug OPC-6535 compared to a placebo in patients with active Ulcerative Colitis.

Depending on their response, participants will be offered the investigational medication for up to one year after the study's completion at select sites.

Conditions

Interventions

DRUG

OPC-6535 Tablets (drug)

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
2003-05-31
Primary Completion
2006-07-31
Completion
2006-07-31

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 NCT00064454 on ClinicalTrials.gov