Study of ONO-2506 in Patients With Acute Ischemic Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00229177
First received: September 27, 2005
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Stroke
Drug: ONO-2506
Phase 2
Phase 3

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

Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • Modified Rankin Scale at 90 days [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modified Rankin Scale at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Glasgow Outcome Scale (GOS) at 90 days [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 757
Study Start Date: September 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: P Drug: ONO-2506
Once daily one-hour intravenous infusion at 0 mg/kg/hr for 7 days
Experimental: E1 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

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00229177

Locations
Japan
Chubu Region Facility
Chubu, Japan
Chugoku Region Facility
Chugoku, Japan
Hokkaido Region Facility
Hokkaido, Japan
Hokuriku Region Facility
Hokuriku, Japan
Kanto Region Facility
Kanto, Japan
Kinki Region Facility
Kinki, Japan
Kyushu Region Facility
Kyushu, Japan
Shikoku Region Facility
Shikoku, Japan
Tohoku Region Facility
Tohuku, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Project Leader, Development Planning Ono Pharmaceutical Co. Ltd
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00229177     History of Changes
Other Study ID Numbers: ONO-2506-08
Study First Received: September 27, 2005
Last Updated: June 12, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-2506
stroke
Acute ischemic stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 18, 2014