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

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ClinicalTrials.gov Identifier: NCT00417326
Recruitment Status : Completed
First Posted : January 1, 2007
Last Update Posted : June 13, 2012
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

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 Phase 2

Study Type : Interventional  (Clinical Trial)
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 : December 2006
Primary Completion Date : August 2009

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

Primary Outcome Measures :
  1. pulmonary function [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. mortality [ Time Frame: 28 days ]
  2. ventilator status [ Time Frame: 28 days ]

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with community-acquired pneumonia
  • Patients with acute respiratory failure

Exclusion Criteria:

  • Patients with nosocomial pneumonia
  • Patients on mechanical ventilation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417326

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, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Study Director: Koji Takehara Ono Pharmaceutical Co. Ltd

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00417326     History of Changes
Other Study ID Numbers: ONO-5046Na-14
First Posted: January 1, 2007    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by Ono Pharmaceutical Co. Ltd:
acute respiratory failure
community-acquired pneumonia

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Glycine Agents
Neurotransmitter Agents
Physiological Effects of Drugs