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A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis

NCT00317356 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2021-04-30

Study results available
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Summary

The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients with active ulcerative colitis.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

OPC-6535(Tetomilast)

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Katsuhisa Saito · Division of New Product Evaluation and Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • Japan

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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 NCT00317356 on ClinicalTrials.gov