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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00034476
First received: April 29, 2002
Last updated: July 18, 2006
Last verified: July 2006
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Estimated Enrollment: 466
Study Start Date: October 2001
Estimated Study Completion Date: October 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00034476

  Show 87 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00034476     History of Changes
Other Study ID Numbers: 1641, J4A-MC-EZZI
Study First Received: April 29, 2002
Last Updated: July 18, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Sepsis, sPLA2 Inhibitor

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 22, 2014