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NCT00417326 Clinical Trial

Controlled Study of ONO-5046Na in Patients With Acute Respiratory Failure Associated With Community-Acquired Pneumonia

Community-acquired Pneumonia Clinical Trial

Official title:
ONO-5046Na Phase II Study - A Pilot Study for Patients With Acute Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00417326
Other study ID # ONO-5046Na-14
Secondary ID
Status Completed
Phase Phase 2
First received December 28, 2006
Last updated June 12, 2012
Start date December 2006

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 safety and efficacy of ONO-5046Na in patients with acute respiratory failure associated with community-acquired pneumonia

Recruitment information / eligibility
Status Completed
Enrollment 174
Est. completion date
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 79 Years
Eligibility Inclusion Criteria:

- Patients with community-acquired pneumonia

- Patients with acute respiratory failure

Exclusion Criteria:

- Patients with nosocomial pneumonia

- Patients on mechanical ventilation

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• ONO-5046Na
twenty four hour infusion at 0 mg/kg/hr for 14 days
• ONO-5046Na
twenty four hour intravenous infusion at 0.2 mg/kg/hr for 14 days

Locations
Country Name City State
Japan Chubu Region Chubu
Japan Chugoku Region Chugoku
Japan Hokkaido Region Hokkaido
Japan Hokuriku Region Hokuriku
Japan Kanto Region Kanto
Japan Kinki Region Kinki
Japan Kyushu Region Kyushu
Japan Shikoku Region Shikoku
Japan Tohoku Region 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 pulmonary function 14 days No
Secondary mortality 28 days No
Secondary ventilator status 28 days No
See also
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