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Completed

NCT Number: NCT00417326

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

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

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Key information

Conditions

Community-Acquired Pneumonia Community-Acquired Infections Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chugoku Region, Chugoku, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with nosocomial pneumonia
  • Patients on mechanical ventilation

Treatment and study plan

ONO-5046Na

Drug

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

Primary outcomes

  1. pulmonary function

    Time frame: 14 days

Secondary outcomes

  1. mortality

    Time frame: 28 days

  2. ventilator status

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
First posted
Jan 1, 2007
Registry last updated
Jun 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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