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NCT00034476 Clinical Trial

A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis

Sepsis Clinical Trial

Official title:
A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00034476
Other study ID # 1641
Secondary ID J4A-MC-EZZI
Status Completed
Phase Phase 1/Phase 2
First received April 29, 2002
Last updated July 18, 2006
Start date October 2001
Est. completion date October 2002

Study information
Verified date July 2006
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 466
Est. completion date October 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria: Patients must

- show evidence of acute infection

- meet specified time windows

- be 18 years of age or older

Exclusion Criteria: Patients must not

- have low white blood cell count

- have undergone certain organ transplants

- be HIV positive

- be pregnant or breast feeding

- have severe underlying medical problems

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• sPLA2 Inhibitor

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Belgium,  Hungary,  Netherlands,  Poland, 

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