Study of ONO-2506 in Patients With Acute Ischemic Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00229177
• Other study ID #: ONO-2506-08
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 27, 2005
• Last updated: June 12, 2012
• Start date: September 2005
• Est. completion date: September 2008

Study information

• Verified date: June 2012
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 757
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• ONO-2506
Once daily one-hour intravenous infusion at 12/mg/kg/hr for 7 days
• ONO-2506
Once daily one-hour intravenous infusion at 0 mg/kg/hr for 7 days
• ONO-2506
Once daily one-hour intravenous infusion at 8 mg/kg/hr for 7 days

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale at 90 days		90 days	No
Secondary	Modified Rankin Scale at 30 days		30 days	No
Secondary	National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Glasgow Outcome Scale (GOS) at 90 days		90 days	No