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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
History of Changes

April 21, 2006
April 28, 2008
May 2006
August 2007   (final data collection date for primary outcome measure)
Clinical improvement rate (number of patients showing clinical improvement/number of patients evaluated x 100) after 8 weeks of study drug administration
Same as current
Complete list of historical versions of study NCT00317369 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Dose-Finding Study of OPC-6535 in Patients With Active Crohn's Disease
A Dose-Finding Study of OPC-6535 in Patients With Active Crohn's Disease

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Crohn Disease
Drug: OPC-6535(Tetomilast)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
16 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00317369
197-05-001, JapicCTI-060217
No
Not Provided
Otsuka Pharmaceutical Co., Ltd.
Not Provided
Study Director: Katsuhisa Saito Study Director, Division of New Product Evaluation and Development
Otsuka Pharmaceutical Co., Ltd.
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP