A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
Information source: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Crohn's Disease
Intervention: Placebo (Drug); OPC-6535 (Drug); OPC-6535 (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Otsuka Pharmaceutical Co., Ltd. Official(s) and/or principal investigator(s): Katsuhisa Saito, Study Chair, Affiliation: OPCJ
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Clinical improvement rate (number of subjects showing clinical improvement / number of subjects evaluated x 100)
Secondary outcome: Clinical improvement rateRemission rate Mean change in CRP level from the baseline Clinical laboratory tests
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
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
Locations and Contacts
Chubu Region, Japan
Chugoku Region, Japan
Hokkaido Region, Japan
Kanto Region, Japan
Kinki Region, Japan
Kyushu Region, Japan
Tohoku Region, Japan
Busan, Korea, Republic of
Daegu, Korea, Republic of
Gyronggi-do, Korea, Republic of
Seoul, Korea, Republic of
Additional Information
Starting date: October 2009
Last updated: February 19, 2013
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