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

Sponsor

Ono Pharmaceutical Co. Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT00417326

Collaborator

(none)

174

Enrollment

Locations

Arms

19.3

Patients Per Site

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Community-acquired Pneumonia	Drug: ONO-5046Na Drug: ONO-5046Na	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

174 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: P	Drug: ONO-5046Na twenty four hour infusion at 0 mg/kg/hr for 14 days
Experimental: E	Drug: ONO-5046Na twenty four hour intravenous infusion at 0.2 mg/kg/hr for 14 days

Arm

Intervention/Treatment

Placebo Comparator: P

Drug: ONO-5046Na

twenty four hour infusion at 0 mg/kg/hr for 14 days

Experimental: E

Drug: ONO-5046Na

twenty four hour intravenous infusion at 0.2 mg/kg/hr for 14 days

Outcome Measures

Primary Outcome Measures

pulmonary function [14 days]

Secondary Outcome Measures

mortality [28 days]
ventilator status [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with community-acquired pneumonia
Patients with acute respiratory failure

Exclusion Criteria:

Patients with nosocomial pneumonia
Patients on mechanical ventilation

Contacts and Locations

Locations

	Site	City	Country
1	Chubu Region	Chubu	Japan
2	Chugoku Region	Chugoku	Japan
3	Hokkaido Region	Hokkaido	Japan
4	Hokuriku Region	Hokuriku	Japan
5	Kanto Region	Kanto	Japan
6	Kinki Region	Kinki	Japan
7	Kyushu Region	Kyushu	Japan
8	Shikoku Region	Shikoku	Japan
9	Tohoku Region	Tohuku	Japan