Back to resultsA Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
OPC-6535
OPC-6535
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility Criteria
Inclusion Criteria:
- Primary lesion in either small intestine or large intestine
- C-reactive protein (CRP) level above the upper limit of the normal range
- Patients who have been receiving a 5-ASA formulation (oral mesalazine) at a fixed dose of 2.25 g/day or higher (not exceeding the approved dose) and at a fixed dosing regimen
- Patients who have not received enteral nutrition or who have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less
Exclusion Criteria:
- Patients with an uncontrolled external fistula (including anal fistula)
- Patients with a history of total proctocolectomy or subtotal colectomy
- Patients with short bowel syndrome
- Patients with an artificial anus
- Patients with serious infectious disease (intra-abdominal abscess, etc)
- Patients with malignant tumor
- Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the trial period
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
OPC-6535 25 mg
OPC-6535 50 mg
Arm Description
oral administration of placebo once-daily for 8weeks
oral administration of OPC-6535 25 mg once-daily for 8 weeks
oral administration of OPC-6535 50mg once-daily for 8 weeks
Outcomes
Primary Outcome Measures
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement / Number of Subjects Evaluated × 100) After 8 Weeks of IMP 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 4 Weeks of IMP Administration
Definition of clinical improvement: 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 Subjects Showing Remission / Number of Subjects Evaluated x 100) After 4 and 8 Weeks of IMP Administration
Definition of remission: Total CDAI score improved to below 150
Mean Change From Baseline in C-reactive Protein (CRP) Level After 4 and 8 Weeks of IMP Administration
Full Information
NCT ID
NCT00989573
First Posted
October 2, 2009
Last Updated
March 11, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00989573
Brief Title
A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
Official Title
A Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to verify the safety and efficacy of OPC-6535 and determine the optimal dose by once-daily oral administration of OPC-6535 at 25 or 50 mg or placebo for 8 weeks in combination with base treatment (either a fixed oral dose of 5-aminosalicylic acid [5-ASA] or a fixed oral dose of 5-ASA plus enteral nutrition) in 180 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's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
191 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
oral administration of placebo once-daily for 8weeks
Arm Title
OPC-6535 25 mg
Arm Type
Experimental
Arm Description
oral administration of OPC-6535 25 mg once-daily for 8 weeks
Arm Title
OPC-6535 50 mg
Arm Type
Experimental
Arm Description
oral administration of OPC-6535 50mg once-daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral administration of placebo once-daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
OPC-6535
Intervention Description
oral administration of OPC-6535 25 mg once-daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
OPC-6535
Intervention Description
oral administration of OPC-6535 50 mg once-daily for 8 weeks
Primary Outcome Measure Information:
Title
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement / Number of Subjects Evaluated × 100) After 8 Weeks of IMP 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 4 Weeks of IMP Administration
Description
Definition of clinical improvement: 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 4
Title
Remission Rate (Number of Subjects Showing Remission / Number of Subjects Evaluated x 100) After 4 and 8 Weeks of IMP Administration
Description
Definition of remission: Total CDAI score improved to below 150
Time Frame
Weeks 4 and 8
Title
Mean Change From Baseline in C-reactive Protein (CRP) Level After 4 and 8 Weeks of IMP Administration
Time Frame
Baseline, Weeks 4 and 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary lesion in either small intestine or large intestine
C-reactive protein (CRP) level above the upper limit of the normal range
Patients who have been receiving a 5-ASA formulation (oral mesalazine) at a fixed dose of 2.25 g/day or higher (not exceeding the approved dose) and at a fixed dosing regimen
Patients who have not received enteral nutrition or who have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less
Exclusion Criteria:
Patients with an uncontrolled external fistula (including anal fistula)
Patients with a history of total proctocolectomy or subtotal colectomy
Patients with short bowel syndrome
Patients with an artificial anus
Patients with serious infectious disease (intra-abdominal abscess, etc)
Patients with malignant tumor
Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the trial period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsuhisa Saito
Organizational Affiliation
OPCJ
Official's Role
Study Chair
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
Tohoku Region
Country
Japan
City
Busan
Country
Korea, Republic of
City
Daegu
Country
Korea, Republic of
City
Gyronggi-do
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
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