Study of ONO-2506 in Patients With Acute Ischemic Stroke

June 12, 2012 updated by: Ono Pharmaceutical Co. Ltd

Controlled Study of ONO-2506 in Patients With Acute Ischemic Stroke

The purpose of this study is to determine the efficacy and safety of ONO-2506 compared to placebo in patients with acute ischemic stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

757

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu, Japan
        • Chubu Region Facility
      • Chugoku, Japan
        • Chugoku Region Facility
      • Hokkaido, Japan
        • Hokkaido Region Facility
      • Hokuriku, Japan
        • Hokuriku Region Facility
      • Kanto, Japan
        • Kanto Region Facility
      • Kinki, Japan
        • Kinki Region Facility
      • Kyushu, Japan
        • Kyushu Region Facility
      • Shikoku, Japan
        • Shikoku Region Facility
      • Tohuku, Japan
        • Tohoku Region Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects who have a clinical diagnosis of acute ischemic stroke
  2. Subjects within 72 hours after onset of the stroke
  3. Other inclusion criteria may apply.

Exclusion Criteria:

  1. Subjects who are scheduled to have surgical operations likely to affect the prognosis (including intravascular surgery and circulatory reconstruction)
  2. Subjects who are pregnant or lactating, or who have child-bearing potential, or who wish to become pregnant.
  3. Other exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: P
Drug: ONO-2506
Once daily one-hour intravenous infusion at 12/mg/kg/hr for 7 days
Drug: ONO-2506
Once daily one-hour intravenous infusion at 0 mg/kg/hr for 7 days
Drug: ONO-2506
Once daily one-hour intravenous infusion at 8 mg/kg/hr for 7 days
Experimental: E2
Drug: ONO-2506
Once daily one-hour intravenous infusion at 12/mg/kg/hr for 7 days
Drug: ONO-2506
Once daily one-hour intravenous infusion at 0 mg/kg/hr for 7 days
Drug: ONO-2506
Once daily one-hour intravenous infusion at 8 mg/kg/hr for 7 days
Experimental: E1
Drug: ONO-2506
Once daily one-hour intravenous infusion at 12/mg/kg/hr for 7 days
Drug: ONO-2506
Once daily one-hour intravenous infusion at 0 mg/kg/hr for 7 days
Drug: ONO-2506
Once daily one-hour intravenous infusion at 8 mg/kg/hr for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modified Rankin Scale at 90 days
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Modified Rankin Scale at 30 days
Time Frame: 30 days
30 days
National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Glasgow Outcome Scale (GOS) at 90 days
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Project Leader, Development Planning, Ono Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria

September 27, 2005

First Posted (Estimate)

September 29, 2005

Study Record Updates

Last Update Posted (Estimate)

June 13, 2012

Last Update Submitted That Met QC Criteria

June 12, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-2506-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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