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

This study has been terminated.
(Efficacy was not cleared at US study)
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00317356
First received: April 21, 2006
Last updated: April 28, 2008
Last verified: April 2008
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Dose-Finding Study of OPC-6535 in Patients With Active Ulcerative Colitis

Resource links provided by NLM:

U.S. FDA Resources

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
Chubu region, Japan
Chugoku region, Japan
Hokkaido region, Japan
Kanto region, Japan
Kinki region, Japan
Kyushu region, Japan
Shikoku region, Japan
Touhoku region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Katsuhisa Saito Division of New Product Evaluation and Development
  More Information

No publications provided

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

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
OPC-6535
ulcerative colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013