A Dose-Finding Study of OPC-6535 in Patients With Active Crohn's Disease - Full Text View

Sponsored by:	Otsuka Pharmaceutical Co., Ltd.
Information provided by:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00317369

Purpose

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

Condition	Intervention	Phase
Crohn Disease	Drug: OPC-6535(Tetomilast)	Phase II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

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 Crohn's Disease

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:

Clinical improvement rate after 2 and 4 weeks of study drug administration
Remission rate (number of patients showing remission/number of patients evaluated x 100) after 2, 4, and 8 weeks of study drug administration
Improvement rate by change in total CDAI score (number of patients for each change/number of patients evaluated x 100) after 2, 4, and 8 weeks of study drug administration
Mean change in total CDAI 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 CDEIS score after 8 weeks of study drug administration
Time course of mean CRP level and mean change in CRP level from the baseline after 4 and 8 weeks of study drug administration

Estimated Enrollment:	60
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:	16 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with active Crohn's disease
Patients who have a primary lesion in either the small intestine or the large intestine
Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose
Patients who have either never received enteral nutrition or have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less
Either inpatient or outpatient

Exclusion Criteria:

Patients who have an external fistula (including anal fistula) in which persistent drainage is observed (and who require treatment with antibiotics or synthetic antibacterial agents)
Patients with short bowel syndrome (and who require intravenous nutritional support due to insufficient intestinal nutrient uptake)
Patients with an artificial anus
Patients who have a complication of serious infectious disease (intra-abdominal abscess, etc.)
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: NCT00317369

Locations

Japan

Hokkaido region, Japan

Touhoku region, Japan

Kanto region, Japan

Kinki region, Japan

Kyushu region, Japan

Shikoku region, Japan

Chubu region, Japan

Chugoku region, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

Study Director:

Katsuhisa Saito

Study Director, Division of New Product Evaluation and Development

More Information

Study ID Numbers:	197-05-001, JapicCTI-060217
Study First Received:	April 21, 2006
Last Updated:	April 28, 2008
ClinicalTrials.gov Identifier:	NCT00317369
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:

OPC-6535
Crohn's disease

Study placed in the following topic categories:

Signs and Symptoms
Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009