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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Colitis, Ulcerative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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OPC-6535(Tetomilast)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with active ulcerative colitis
* Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose
* Either inpatient or outpatient

Exclusion Criteria

* Patients who have a history of intestinal resection (other than appendiceal resection)
* Patients who have a complication of malignant tumor
* Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No