Back to resultsA Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease
Primary Purpose
Crohn Disease
Status
Terminated
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
OPC-6535(Tetomilast)
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease focused on measuring OPC-6535, Crohn's disease
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration
Definition of clinical improvement: Total Crohn's Disease Activity Index (CDAI) score improved by at least 70 points from the baseline score or to below 150 (CDAI < 150: Remission, CDAI > 450: severe disease)
Secondary Outcome Measures
Clinical Improvement Rate After 2 and 4 Weeks of Study Drug Administration
Definition of clinical improvement: Total CDAI score improved by at least 70 points from the baseline score or to below 150 (CDAI < 150: Remission, CDAI > 450: severe disease)
Remission Rate (Number of Patients Showing Remission/Number of Patients Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration
Definition of remission: Total CDAI score improved to below 150
Clinical Improvement Rate (50) by Change in Total CDAI Score (Number of Subjects for Each Change/Number of Subjects Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration
Definition of clinical improvement (50) : Total CDAI score improved by at least 50 points from the baseline score or to below 150 (CDAI < 150: Remission, CDAI > 450: severe disease)
Mean Change From Baseline in Total CDAI Score After 2, 4, and 8 Weeks of Study Drug Administration
CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity (CDAI < 150: Remission, CDAI > 450: Very severe). A negative change in mean score indicates improvement.
Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration
The IBDQ has been frequently adopted in Japanese and overseas clinical assessments as a scale for evaluating the quality of life (QOL) of patients with inflammatory bowel disease. The IBDQ score was calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions that address symptoms as a result of Crohn's disease: bowel symptoms, systemic symptoms, emotional function, and social function. Total IBDQ score ranges from 32 to 224 with a higher score indicating a better QOL.
Mean Change From the Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score After 8 Weeks of Study Drug Administration
Large bowel endoscopic findings were assessed based on the CDEIS. The CDEIS considers deep ulcer, superficial ulcer, lesion ratio of , and ulcer ratio of the 5 pre-defined segments of the colon (small intestine, right colon, transverse colon, left colon, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe disease.
Mean Change in C-reactive Protein (CRP) Level From the Baseline After 4 and 8 Weeks of Study Drug Administration
Full Information
NCT ID
NCT00317369
First Posted
April 21, 2006
Last Updated
January 26, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00317369
Brief Title
A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease
Official Title
A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Efficacy was not cleared at US study
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 11, 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
OPC-6535, Crohn's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
OPC-6535(Tetomilast)
Primary Outcome Measure Information:
Title
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration
Description
Definition of clinical improvement: Total Crohn's Disease Activity Index (CDAI) score improved by at least 70 points from the baseline score or to below 150 (CDAI < 150: Remission, CDAI > 450: severe disease)
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Clinical Improvement Rate After 2 and 4 Weeks of Study Drug Administration
Description
Definition of clinical improvement: Total CDAI score improved by at least 70 points from the baseline score or to below 150 (CDAI < 150: Remission, CDAI > 450: severe disease)
Time Frame
Week 2, Week 4
Title
Remission Rate (Number of Patients Showing Remission/Number of Patients Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration
Description
Definition of remission: Total CDAI score improved to below 150
Time Frame
Week 2, Week 4，Week 8
Title
Clinical Improvement Rate (50) by Change in Total CDAI Score (Number of Subjects for Each Change/Number of Subjects Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration
Description
Definition of clinical improvement (50) : Total CDAI score improved by at least 50 points from the baseline score or to below 150 (CDAI < 150: Remission, CDAI > 450: severe disease)
Time Frame
Baseline, Weeks 2, 4, and 8
Title
Mean Change From Baseline in Total CDAI Score After 2, 4, and 8 Weeks of Study Drug Administration
Description
CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity (CDAI < 150: Remission, CDAI > 450: Very severe). A negative change in mean score indicates improvement.
Time Frame
Baseline, Weeks 2, 4, and 8
Title
Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration
Description
The IBDQ has been frequently adopted in Japanese and overseas clinical assessments as a scale for evaluating the quality of life (QOL) of patients with inflammatory bowel disease. The IBDQ score was calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions that address symptoms as a result of Crohn's disease: bowel symptoms, systemic symptoms, emotional function, and social function. Total IBDQ score ranges from 32 to 224 with a higher score indicating a better QOL.
Time Frame
Baseline, Week 8
Title
Mean Change From the Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score After 8 Weeks of Study Drug Administration
Description
Large bowel endoscopic findings were assessed based on the CDEIS. The CDEIS considers deep ulcer, superficial ulcer, lesion ratio of , and ulcer ratio of the 5 pre-defined segments of the colon (small intestine, right colon, transverse colon, left colon, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe disease.
Time Frame
Baseline, Week 8
Title
Mean Change in C-reactive Protein (CRP) Level From the Baseline After 4 and 8 Weeks of Study Drug Administration
Time Frame
Baseline, Weeks 4 and 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsuhisa Saito
Organizational Affiliation
Study Director, Division of New Product Evaluation and Development
Official's Role
Study Director
Facility Information:
City
Chubu Region
Country
Japan
City
Chugoku Region
Country
Japan
City
Hokkaido region
Country
Japan
City
Kanto Region
Country
Japan
City
Kinki Region
Country
Japan
City
Kyushu Region
Country
Japan
City
Shikoku Region
Country
Japan
City
Touhoku Region
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease
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