Clinical trial NCT00989573: A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
Official title: A Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Crohn's Disease
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-10-05
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 combination with base treatment (either a fixed oral dose of 5-aminosalicylic acid \[5-ASA\] or a fixed oral dose of 5-ASA plus enteral nutrition) in 180 patients with active Crohn's disease.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement / Number of Subjects Evaluated × 100) After 8 Weeks of IMP Administration
timeFrame: Week 8
Secondary outcomes:
measure: Clinical Improvement Rate After 4 Weeks of IMP Administration
timeFrame: Week 4
measure: Remission Rate (Number of Subjects Showing Remission / Number of Subjects Evaluated x 100) After 4 and 8 Weeks of IMP Administration
timeFrame: Weeks 4 and 8
measure: Mean Change From Baseline in C-reactive Protein (CRP) Level After 4 and 8 Weeks of IMP 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: Tohoku Region
country: Japan
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Gyronggi-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: OPCJ
name: Katsuhisa Saito
role: STUDY_CHAIR
References: