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

Otsuka

Status and phase: Completed; Phase 3; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: OPC-6535; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00989573

197-08-001

JapicCTI090915

Details and patient eligibility

About

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.

Enrollment: 191 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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191 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

oral administration of placebo once-daily for 8weeks

Treatment:

Drug: Placebo

OPC-6535 25 mg

Experimental group

Description:

oral administration of OPC-6535 25 mg once-daily for 8 weeks

Treatment:

Drug: OPC-6535

Drug: OPC-6535

OPC-6535 50 mg

Experimental group

Description:

oral administration of OPC-6535 50mg once-daily for 8 weeks

Treatment:

Drug: OPC-6535

Drug: OPC-6535