Status:
TERMINATED
A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Crohn Disease
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
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 ora...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00317369
Start Date
May 1 2006
End Date
August 1 2007
Last Update
February 15 2021
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Chubu Region, Japan
2
Chugoku Region, Japan
3
Hokkaido Region, Japan
4
Kanto Region, Japan