Status:
TERMINATED
A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in com...
Eligibility Criteria
Inclusion
- Patients with active ulcerative colitis
- Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose
- Either inpatient or outpatient
Exclusion
- Patients who have a history of intestinal resection (other than appendiceal resection)
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00317356
Start Date
May 1 2006
End Date
August 1 2007
Last Update
April 30 2021
Active Locations (8)
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1
Chubu Region, Japan
2
Chugoku Region, Japan
3
Hokkaido Region, Japan
4
Kanto Region, Japan