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A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects with Acute Lung Injury Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects with Acute Lung Injury conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects with Acute Lung Injury Clinical research trials and A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects with Acute Lung Injury health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects with Acute Lung Injury. A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects with Acute Lung Injury Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects with Acute Lung Injury clinical trial. Participants oftentimes recieve the most expert healthcare available for their A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects with Acute Lung Injury condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.

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A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects with Acute Lung Injury



A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects with Acute Lung Injury

For Condition: Acute Lung Injury,Respiratory Distress Syndrome, Adult
Status: No longer recruiting
Sponsor(s): Eli Lilly and Company ,
Synopsis: The purpose of this study is to determine whether sivelestat will reduce the amount of time a patient must spend on a ventilator and/or increase the chance of survival of patients with acute lung injury.
Details: Acute lung injury often develops as a result of severe infection, sepsis, severe injuries, inhalation of foreign substances into the lungs, or pneumonia. The tissues and blood vessels in the lungs become inflammed, and the body does not receive enough oxygen. Patients with this condition are placed on a ventilator to assist with breathing. Patients entered into this study will be randomly assigned to one of two treatment groups: a sivelestat group or a placebo group. Once entered into the study, patients are monitored for up to 6 months.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - show evidence of acute lung injury - be on mechanical ventilation Exclusion Criteria - have undergone certain organ transplants - have severe underlying medical problems - be unlikely to survive - be pregnant or breast-feeding
Total Enrollment: 600

Location and Contact Information:


Additional Information:
Study ID Numbers:
  6025; 
Study Start Date: August 2001
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036062

Other Acute Lung Injury Studies:
1. Phase I Study of Vasoactive Intestinal Peptide in Patients with Acute Respiratory Distress Syndrome and Sepsis

2. Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation

3. A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects with Acute Lung Injury

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