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| Sponsor: | Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00034476 |
Purpose
The purpose of this study is to determine whether the administration of the study drug is effective in increasing the chance of survival in patients with severe sepsis. Patients entered into this study will be randomly assigned to one of two treatment groups. Patients in each treatment group will be given either the study drug or placebo as a continuous infusion directly into the bloodstream through a catheter placed in one of the patient's veins.
The study drug is an investigational drug that is still in development. It has been studied in approximately 30 healthy subjects, approximately 30 patients with either kidney failure or arthritis, and approximately 600 patients with severe sepsis. Patient participation in this study will last for about one month.
| Condition | Intervention | Phase |
|---|---|---|
|
Sepsis |
Drug: sPLA2 Inhibitor |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: Patients must
Exclusion Criteria: Patients must not
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Birmingham, Alabama, United States | |
| United States, Arizona | |
| Phoenix, Arizona, United States | |
| United States, California | |
| San Diego, California, United States | |
| Orange, California, United States | |
| Los Angeles, California, United States | |
| Torrance, California, United States | |
| Berkeley, California, United States | |
| United States, Colorado | |
| Denver, Colorado, United States | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| Miami, Florida, United States | |
| Orlando, Florida, United States | |
| Tampa, Florida, United States | |
| Lakeland, Florida, United States | |
| Brandon, Florida, United States | |
| Clearwater, Florida, United States | |
| United States, Georgia | |
| Augusta, Georgia, United States | |
| United States, Illinois | |
| Oak Park, Illinois, United States | |
| Springfield, Illinois, United States | |
| Chicago, Illinois, United States | |
| United States, Indiana | |
| Indianapolis, Indiana, United States | |
| United States, Iowa | |
| Iowa, Iowa, United States | |
| Des Moines, Iowa, United States | |
| United States, Kansas | |
| Kansas City, Kansas, United States | |
| United States, Kentucky | |
| Lexington, Kentucky, United States | |
| United States, Louisiana | |
| Lake Charles, Louisiana, United States | |
| New Orleans, Louisiana, United States | |
| Shreveport, Louisiana, United States | |
| United States, Maine | |
| Portland, Maine, United States | |
| United States, Maryland | |
| Baltimore, Maryland, United States | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States | |
| Springfield, Massachusetts, United States | |
| United States, Michigan | |
| Detroit, Michigan, United States | |
| Ann Arbor, Michigan, United States | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States | |
| United States, Missouri | |
| St. Lous, Missouri, United States | |
| United States, Nevada | |
| Reno, Nevada, United States | |
| United States, New Jersey | |
| East Orange, New Jersey, United States | |
| New Brunswick, New Jersey, United States | |
| United States, New York | |
| Great Neck, New York, United States | |
| New York, New York, United States | |
| New Hyde Park, New York, United States | |
| Manhasset, New York, United States | |
| Bronx, New York, United States | |
| United States, North Carolina | |
| Greensboro, North Carolina, United States | |
| Winston-Salem, North Carolina, United States | |
| Chapel Hill, North Carolina, United States | |
| United States, Ohio | |
| Toledo, Ohio, United States | |
| Akron, Ohio, United States | |
| United States, Oregon | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Pittsburg, Pennsylvania, United States | |
| Philadelphia, Pennsylvania, United States | |
| Hershey, Pennsylvania, United States | |
| United States, Rhode Island | |
| Providence, Rhode Island, United States | |
| United States, Tennessee | |
| Memphis, Tennessee, United States | |
| United States, Texas | |
| Houston, Texas, United States | |
| San Antonio, Texas, United States | |
| United States, Virginia | |
| Falls Church, Virginia, United States | |
| United States, Washington | |
| Seattle, Washington, United States | |
| United States, Wisconsin | |
| Madison, Wisconsin, United States | |
| Milwaukee, Wisconsin, United States | |
| Belgium | |
| Bruxelles, Belgium | |
| Gent, Belgium | |
| Brussels, Belgium | |
| Yvior, Belgium | |
| Liege, Belgium | |
| Ottignies, Belgium | |
| Hungary | |
| Debrecend, Hungary | |
| Budapest, Hungary | |
| Szeged, Hungary | |
| Pecs, Hungary | |
| Miskolc, Hungary | |
| Debrecen, Hungary | |
| Vac, Hungary | |
| Netherlands | |
| Nijmegen, Netherlands | |
| Breda, Netherlands | |
| Den Bosch, Netherlands | |
| Rotterdam, Netherlands | |
| Groningen, Netherlands | |
| Apeldoorn, Netherlands | |
| Poland | |
| Wroclaw, Poland | |
| Szczecin, Poland | |
| Sosnowiec, Poland | |
| Warszawa, Poland | |
| Krakow-Nowa Huta, Poland | |
| Warsaw, Poland | |
| Poznan, Poland | |
| Gdansk, Poland | |
More Information
| Study ID Numbers: | 1641, J4A-MC-EZZI |
| Study First Received: | April 29, 2002 |
| Last Updated: | July 18, 2006 |
| ClinicalTrials.gov Identifier: | NCT00034476 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Sepsis, sPLA2 Inhibitor |
|
Systemic Inflammatory Response Syndrome Sepsis Pathologic Processes Infection Inflammation |
