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

This study has been terminated.
(Efficacy was not cleared at US study)
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00317369
First received: April 21, 2006
Last updated: April 28, 2008
Last verified: April 2008
  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 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 Crohn's Disease

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317369

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 Study Director, Division of New Product Evaluation and Development
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00317369     History of Changes
Other Study ID Numbers: 197-05-001, JapicCTI-060217
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
Crohn's disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 22, 2014