Clinical trial NCT00317369: A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease
Official title: A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn Disease
Keywords: OPC-6535
Crohn's disease
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2006-04-24
Enrollment: 29
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration
timeFrame: Week 8
Secondary outcomes:
measure: Clinical Improvement Rate After 2 and 4 Weeks of Study Drug Administration
timeFrame: Week 2, Week 4
measure: Remission Rate (Number of Patients Showing Remission/Number of Patients Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration
timeFrame: Week 2, Week 4，Week 8
measure: Clinical Improvement Rate (50) by Change in Total CDAI Score (Number of Subjects for Each Change/Number of Subjects Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration
timeFrame: Baseline, Weeks 2, 4, and 8
measure: Mean Change From Baseline in Total CDAI Score After 2, 4, and 8 Weeks of Study Drug Administration
timeFrame: Baseline, Weeks 2, 4, and 8
measure: Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration
timeFrame: Baseline, Week 8
measure: Mean Change From the Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score After 8 Weeks of Study Drug Administration
timeFrame: Baseline, Week 8
measure: Mean Change in C-reactive Protein (CRP) Level From the Baseline After 4 and 8 Weeks of Study Drug Administration
timeFrame: Baseline, Weeks 4 and 8
Other outcomes:
Locations:
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: Shikoku Region
country: Japan
city: Touhoku Region
country: Japan
Study officials:
affiliation: Study Director, Division of New Product Evaluation and Development
name: Katsuhisa Saito
role: STUDY_DIRECTOR
References: