SB-681323 IV for Subjects at Risk of Acute Lung Injury or ARDS
Public ClinicalTrials.gov record NCT00996840. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
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).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00996840
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 77 participants
Conditions and interventions
Conditions
Interventions
- SB-681323 Intravenous 3mg Drug
- SB-681323 Intravenous 7.5 mg Drug
- SB-681323 Intravenous 7.5mg Drug
- SB-681323 Intravenous 10mg Drug
- Placebo Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 16, 2009 (Actual)
- Primary completion
- Feb 9, 2013 (Actual)
- Completion
- Feb 9, 2013 (Actual)
- Last update posted
- Oct 18, 2017
2009 – 2013
United States locations
- U.S. sites
- 6
- U.S. states
- 4
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Lexington | Kentucky | 40536-0293 | — |
| GSK Investigational Site | Durham | North Carolina | 27710 | — |
| GSK Investigational Site | Winston-Salem | North Carolina | 27157 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15213 | — |
| GSK Investigational Site | Nashville | Tennessee | 37232-7110 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00996840, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 18, 2017 · Synced Nov 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00996840 live on ClinicalTrials.gov.