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SB-681323 IV for Subjects at Risk of Acute Lung Injury or ARDS

NCT00996840 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2017-10-18

Study results available
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Summary

This is an early phase (Phase IIa), randomized, double-blind, parallel group, multi-centre study for subjects with trauma (physical injury) who are at risk for developing Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS). The primary purpose of the study is to evaluate the safety and tolerability of SB-681323, which is a potent, selective inhibitor of p38 alpha (MAPK) (prevents inflammation of tissue), in comparison to a placebo.

Conditions

  • Lung Injury, Acute

Interventions

DRUG

SB-681323 Intravenous 3mg

3 mg SB-681323 Intravenous administration infused over 4 hours

DRUG

SB-681323 Intravenous 7.5 mg

7.5 mg SB-681323 Intravenous administration infused over 24 hours

DRUG

SB-681323 Intravenous 7.5mg

7.5 mg SB-681323 Intravenous administration infused over 4 hours

DRUG

SB-681323 Intravenous 10mg

10 mg SB-681323 Intravenous administration infused over 24 hours

OTHER

Placebo

Placebo to match intervention

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-16
Primary Completion
2013-02-09
Completion
2013-02-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00996840 on ClinicalTrials.gov