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

NCT00989573 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2021-04-06

Study results available
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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.

Conditions

Interventions

DRUG

Placebo

oral administration of placebo once-daily for 8 weeks

DRUG

OPC-6535

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

DRUG

OPC-6535

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

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Katsuhisa Saito · OPCJ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Japan
  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00989573 on ClinicalTrials.gov