At a glance
ClinicalIndex Comparison Record- ✓Age 18–80 years with major trauma admitted to ICU
- ✓Injury Severity Score (ISS) >16 to <70 (exclusive)
- ✓BMI 19.0–35.0 kg/m² (inclusive)
- ✓QTcB or QTcF <450 msec; or QTc <480 msec with Bundle Branch Block
- ✕Diagnosis of ALI (acute lung injury) at admission
- ✕Head trauma with Abbreviated Injury Score (AIS) >3
- ✕Liver trauma with AIS >2
- ✕Trauma deemed unsurvivable by investigator or GSK medical monitor
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Assessment of the Anti-Inflammatory Activity, Efficacy and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS).
In Brief
A Phase 2 clinical trial evaluating SB-681323 Intravenous 3mg, SB-681323 Intravenous 7.5 mg, and 3 other interventions for Lung Injury, Acute. Completed, enrolled 77 participants across 6 sites.
Detailed 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.
Study Details
Timeline
Interventions
3 mg SB-681323 Intravenous administration infused over 4 hours
7.5 mg SB-681323 Intravenous administration infused over 24 hours
7.5 mg SB-681323 Intravenous administration infused over 4 hours
10 mg SB-681323 Intravenous administration infused over 24 hours
Placebo to match intervention