A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00989573
• Date of registration: 02/10/2009
• Prospective Registration: No
• Primary sponsor: Otsuka Pharmaceutical Co., Ltd.
• Public title: A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
• Scientific title: A Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease
• Date of first enrolment: October 2009
• Target sample size: 191
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00989573
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Japan, Korea, Republic of

Contacts

• Name: Katsuhisa Saito
• Affiliation: OPCJ

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: OPC-6535

Drug: Placebo

Primary Outcome(s)

Clinical improvement rate (number of subjects showing clinical improvement / number of subjects evaluated x 100) [Time Frame: after 8 weeks]

Secondary Outcome(s)

Clinical laboratory tests [Time Frame: after 2, 4, 8 weeks]

Remission rate [Time Frame: after 4, 8 weeks]

Mean change in CRP level from the baseline [Time Frame: after 4, 8 weeks]

Clinical improvement rate [Time Frame: after 4 weeks]

Secondary ID(s)

JapicCTI090915

197-08-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors