A Dose-Finding Study of OPC-6535 in Patients With Active Crohn's Disease
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ClinicalTrials.gov Identifier: NCT00317369
(Efficacy was not cleared at US study)
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.
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Ages Eligible for Study:
16 Years to 65 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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