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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

oral administration of placebo once-daily for 8weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral administration of placebo once-daily for 8 weeks

OPC-6535 25 mg

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

Group Type EXPERIMENTAL

OPC-6535

Intervention Type DRUG

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

OPC-6535 50 mg

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

Group Type EXPERIMENTAL

OPC-6535

Intervention Type DRUG

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

Interventions

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Placebo

oral administration of placebo once-daily for 8 weeks

Intervention Type DRUG

OPC-6535

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

Intervention Type DRUG

OPC-6535

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No