A Dose-Finding Study of OPC-6535 in Patients With Active Ulcerative Colitis - Full Text View

Sponsored by:	Otsuka Pharmaceutical Co., Ltd.
Information provided by:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00317356

Purpose

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.

Condition	Intervention	Phase
Colitis, Ulcerative	Drug: OPC-6535(Tetomilast)	Phase II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Tetomilast

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Dose-Finding Study of OPC-6535 in Patients With Active Ulcerative Colitis

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

Clinical improvement rate (number of patients showing clinical improvement/number of patients evaluated x 100) after 8 weeks of study drug administration

Secondary Outcome Measures:

Remission rate (number of patients showing remission/number of patients evaluated x 100) after 4 and 8 weeks of study drug administration
Mean change from the baseline in total Disease Activity Index (DAI) score after 4 and 8 weeks of study drug administration
Mean change from the baseline in DAI subscores after 4 and 8 weeks of study drug administration
Mean change from the baseline in total Clinical Activity Index (CAI) score after 2, 4, and 8 weeks of study drug administration
Mean change from the baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score after 8 weeks of study drug administration
Mean change from the baseline in IBDQ subscale scores after 8 weeks of study drug administration
Clinical improvement rate after 4 weeks of study drug administration

Estimated Enrollment:	160
Study Start Date:	May 2006
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317356

Locations

Japan

Hokkaido region, Japan

Touhoku region, Japan

Kanto region, Japan

Chubu region, Japan

Kyushu region, Japan

Chugoku region, Japan

Shikoku region, Japan

Kinki region, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

Study Director:

Katsuhisa Saito

Division of New Product Evaluation and Development

More Information

Study ID Numbers:	197-05-002, JapicCTI-060216
Study First Received:	April 21, 2006
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00317356
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:

OPC-6535
ulcerative colitis

Study placed in the following topic categories:

Signs and Symptoms
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases

Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009