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NCT00996840 · ClinicalTrials.gov registry record · Phase 2
SB-681323 IV for Subjects at Risk of Acute Lung Injury or ARDS
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
NCT00996840: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00996840 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 77 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00996840, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
Study 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.
Primary Outcome
Mean hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, white blood cell count were reported. If sample for hematology test had been obtained for standard of care within ± 4 h of the planned assessment then it was not collected at the planned assessment time point.
Interventions
- OTHER Placebo
- DRUG SB-681323 Intravenous 3mg
- DRUG SB-681323 Intravenous 7.5 mg
- DRUG SB-681323 Intravenous 7.5mg
- DRUG SB-681323 Intravenous 10mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2009-10-16 |
| Est. Completion | 2013-02-09 |
| Phase | Phase 2 |
What the finished NCT00996840 record still lists
NCT00996840 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00996840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00996840 about?
NCT00996840 is a clinical study titled "SB-681323 IV for Subjects at Risk of Acute Lung Injury or ARDS". 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...
What is the current status of trial NCT00996840?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2009-10-16. Estimated completion is 2013-02-09.
What interventions are being tested in trial NCT00996840?
The interventions under investigation include: Placebo (OTHER), SB-681323 Intravenous 3mg (DRUG), SB-681323 Intravenous 7.5 mg (DRUG), SB-681323 Intravenous 7.5mg (DRUG), SB-681323 Intravenous 10mg (DRUG).
Who is sponsoring clinical trial NCT00996840?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00996840's enrollment target sits among peer trials
77 891st of 2000 higher than 1,108 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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