This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd Identifier:
First received: December 28, 2006
Last updated: June 12, 2012
Last verified: June 2012
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 Intervention Phase
Community-acquired Pneumonia Drug: ONO-5046Na Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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

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

Secondary Outcome Measures:
  • mortality [ Time Frame: 28 days ]
  • ventilator status [ Time Frame: 28 days ]

Enrollment: 174
Study Start Date: December 2006
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  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 identifier: 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
  More Information

Responsible Party: Ono Pharmaceutical Co. Ltd Identifier: NCT00417326     History of Changes
Other Study ID Numbers: ONO-5046Na-14
Study First Received: December 28, 2006
Last Updated: June 12, 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 processed this record on August 18, 2017