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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:
ClinicalTrials.gov Identifier:
NCT00317369
First Posted: April 24, 2006
Last Update Posted: May 6, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00317369     History of Changes
Other Study ID Numbers: 197-05-001
JapicCTI-060217
First Submitted: April 21, 2006
First Posted: April 24, 2006
Last Update Posted: May 6, 2008
Last Verified: April 2008

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