Status:
COMPLETED
A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
PHASE3
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 combina...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT00989573
Start Date
October 1 2009
End Date
August 1 2012
Last Update
April 6 2021
Active Locations (11)
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1
Chubu Region, Japan
2
Chugoku Region, Japan
3
Hokkaido Region, Japan
4
Kanto Region, Japan