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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 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 77 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00996840
The ClinicalTrials.gov registry entry for NCT00996840 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00996840 reports 0 study locations.
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.
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