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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00417326
First received: December 28, 2006
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • ventilator status [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00417326

Locations
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, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Koji Takehara Ono Pharmaceutical Co. Ltd
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00417326     History of Changes
Other Study ID Numbers: ONO-5046Na-14
Study First Received: December 28, 2006
Last Updated: June 12, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-5046Na
acute respiratory failure
community-acquired pneumonia

Additional relevant MeSH terms:
Pneumonia
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Sivelestat
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014