Trial · NCT00996840
SB-681323 IV for Subjects at Risk of Acute Lung Injury or ARDS
NCT00996840, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-10-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SB-681323 IV for Subjects at Risk of Acute Lung Injury or ARDS. Trials, record NCT00996840. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00996840
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SB-681323 IV for Subjects at Risk of Acute Lung Injury or ARDS
- NCT number
- NCT00996840
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 77 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Lung Injury, Acute
- Interventions
- SB-681323 Intravenous 3mg, SB-681323 Intravenous 7.5 mg, SB-681323 Intravenous 7.5mg, SB-681323 Intravenous 10mg, Placebo
- First posted
- 2009-10-16
- Last updated
- 2017-10-18
- Results first posted
- 2017-10-18
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count | "Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" | 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. |
| Primary | Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | "Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" | Mean hematology parameters including hemoglobin, MCHC 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. |
| Primary | Mean Hematology Parameters- Mean Corpuscle Hemoglobin | "Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" | Hematology parameter mean corpuscle hemoglobin was 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. |
| Primary | Hematology Parameters-Mean Corpuscle Volume | "Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" | Absolute values of mean corpuscle volume 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. |
| Primary | Mean Hematology Parameters-reticulocytes, Red Blood Cell Count | "Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" | Absolute values of reticulocytes and red 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. |
| Primary | Mean Clinical Chemistry Parameters- Albumin and Total Protein | "Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" | Absolute values of albumin and total protein were reported. If sample for clinical chemistry 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. |
| Primary | Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase | "Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" | Absolute values of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase were reported. If sample for clinical chemistry 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. |
| Primary | Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | "Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" | Absolute values of direct bilirubin, total bilirubin, creatinine and uric acid were reported. If sample for clinical chemistry 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. |
| Primary | Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN) | "Day 2, pre-dose", "Day 3, pre-dose", "Day 3, 24 h" and "Follow up (Day 7)" | Absolute values of calcium, chloride, glucose, bicarbonate, potassium, sodium and Urea/BUN were reported. If sample for clinical chemistry 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. |
| Primary | Mean Clinical Chemistry Parameters-estradiol | Day 1 (pre-dose) and Day 3 (24 h) | Absolute values of Estradiol were reported. If sample for clinical chemistry 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. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count | Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7) | All subject Population comprised of as all participant who received at least one dose of study medication. Only those participants available at the specified time points were analyzed. | Giga cells per liter | MEAN |
| PRIMARY | Mean Hematology Parameters- Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC) | Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7) | All subject population. Only those participants available at the specified time points were analyzed. | Grams per liter (g/L) | MEAN |
| PRIMARY | Mean Hematology Parameters- Mean Corpuscle Hemoglobin | Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7) | All subject population. Only those participants available at the specified time points were analyzed. | Picogram (pg) | MEAN |
| PRIMARY | Hematology Parameters-Mean Corpuscle Volume | Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7) | All subject population. Only those participants available at the specified time points were analyzed. | Femtoliter | MEAN |
| PRIMARY | Mean Hematology Parameters-reticulocytes, Red Blood Cell Count | Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7) | All subject population. Only those participants available at the specified time points were analyzed. | Trillion cells per liter (TI/L) | MEAN |
| PRIMARY | Mean Clinical Chemistry Parameters- Albumin and Total Protein | Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7) | All subject population. Only those participants available at the specified time points were analyzed. | g/L | MEAN |
| PRIMARY | Mean Clinical Chemistry Parameters-alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase | Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7) | All subject population. Only those participants available at the specified time points were analyzed. | International units per liter (IU/L) | MEAN |
| PRIMARY | Mean Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid | Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7) | All subject population. Only those participants available at the specified time points were analyzed. | Micromol per liter | MEAN |
| PRIMARY | Mean Clinical Chemistry Parameters- Calcium, Chloride, Glucose, Bicarbonate, Potassium, Sodium and Ratio of Urea to Blood Urea Nitrogen (Urea/BUN) | Day 2, pre-dose, Day 3, pre-dose, Day 3, 24 h and Follow up (Day 7) | All subject population. Only those participants available at the specified time points were analyzed. | Millimole per liter | MEAN |
| PRIMARY | Mean Clinical Chemistry Parameters-estradiol | Day 1 (pre-dose) and Day 3 (24 h) | All subject population. Only those participants available at the specified time points were analyzed. Data were not collected from participants in Cohort 2-SB-681323, 7.5 mg, 24 h, Cohort 3-SB-681323, 7.5 mg, 4 h, and Cohort 4-SB-681323, 10 mg, 24 h. | Picomole per liter | MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group1,060
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count | Combined Placebo | Basophils: Day 2, pre-dose | 0.0305 | Standard Deviation 0.04196 | Giga cells per liter |
| Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count | Cohort 1-SB-681323, 3 mg, 4 h | Basophils: Day 2, pre-dose | 0.0163 | Standard Deviation 0.01188 | Giga cells per liter |
| Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count | Cohort 2-SB-681323, 7.5 mg, 24 h | Basophils: Day 2, pre-dose | 0.0208 | Standard Deviation 0.02843 | Giga cells per liter |
| Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count | Cohort 3-SB-681323, 7.5 mg, 4 h | Basophils: Day 2, pre-dose | 0.0153 | Standard Deviation 0.01125 | Giga cells per liter |
| Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count | Cohort 4-SB-681323, 10 mg, 24 h | Basophils: Day 2, pre-dose | 0.0258 | Standard Deviation 0.02134 | Giga cells per liter |
| Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count | Combined Placebo | Basophils: Day 3, pre-dose | 0.0291 | Standard Deviation 0.03036 | Giga cells per liter |
| Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count | Cohort 1-SB-681323, 3 mg, 4 h | Basophils: Day 3, pre-dose | 0.0129 | Standard Deviation 0.00756 | Giga cells per liter |
| Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count | Cohort 2-SB-681323, 7.5 mg, 24 h | Basophils: Day 3, pre-dose | 0.0209 | Standard Deviation 0.02737 | Giga cells per liter |
| Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count | Cohort 3-SB-681323, 7.5 mg, 4 h | Basophils: Day 3, pre-dose | 0.0176 | Standard Deviation 0.01562 | Giga cells per liter |
| Mean Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell Count | Cohort 4-SB-681323, 10 mg, 24 h | Basophils: Day 3, pre-dose | 0.0279 | Standard Deviation 0.03191 | Giga cells per liter |
1 to 10 of 1,060Source ClinicalTrials.gov
See all 1,060 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combined Placebo | 20 | |
| Overall Study | STARTED | Cohort 1-SB-681323, 3 mg, 4 h | 9 | |
| Overall Study | STARTED | Cohort 2-SB-681323, 7.5 mg, 24 h | 12 | |
| Overall Study | STARTED | Cohort 3-SB-681323, 7.5 mg, 4 h | 18 | |
| Overall Study | STARTED | Cohort 4-SB-681323, 10 mg, 24 h | 18 | |
| Overall Study | COMPLETED | Combined Placebo | 19 | |
| Overall Study | COMPLETED | Cohort 1-SB-681323, 3 mg, 4 h | 7 | |
| Overall Study | COMPLETED | Cohort 2-SB-681323, 7.5 mg, 24 h | 11 | |
| Overall Study | COMPLETED | Cohort 3-SB-681323, 7.5 mg, 4 h | 17 | |
| Overall Study | COMPLETED | Cohort 4-SB-681323, 10 mg, 24 h | 16 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events465
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Feeding disorder | Metabolism and nutrition disorders | Combined Placebo | 4 | 20 | |
| other | Feeding disorder | Metabolism and nutrition disorders | Cohort 1-SB-681323, 3 mg, 4 h | 1 | 9 | |
| other | Feeding disorder | Metabolism and nutrition disorders | Cohort 2-SB-681323, 7.5 mg, 24 h | 1 | 12 | |
| other | Feeding disorder | Metabolism and nutrition disorders | Cohort 3-SB-681323, 7.5 mg, 4 h | 0 | 18 | |
| other | Feeding disorder | Metabolism and nutrition disorders | Cohort 4-SB-681323, 10 mg, 24 h | 0 | 18 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Combined Placebo | 1 | 20 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Cohort 1-SB-681323, 3 mg, 4 h | 0 | 9 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Cohort 2-SB-681323, 7.5 mg, 24 h | 1 | 12 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Cohort 3-SB-681323, 7.5 mg, 4 h | 4 | 18 | |
| other | Hyperglycaemia | Metabolism and nutrition disorders | Cohort 4-SB-681323, 10 mg, 24 h | 0 | 18 |
1 to 10 of 465Source ClinicalTrials.gov
See all 465 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combined Placebo | 0 | 20 |
| Total, all-cause mortality | Cohort 1-SB-681323, 3 mg, 4 h | 0 | 9 |
| Total, all-cause mortality | Cohort 2-SB-681323, 7.5 mg, 24 h | 0 | 12 |
| Total, all-cause mortality | Cohort 3-SB-681323, 7.5 mg, 4 h | 0 | 18 |
| Total, all-cause mortality | Cohort 4-SB-681323, 10 mg, 24 h | 0 | 18 |
| Total, other adverse events | Combined Placebo | 18 | 20 |
| Total, other adverse events | Cohort 1-SB-681323, 3 mg, 4 h | 7 | 9 |
| Total, other adverse events | Cohort 2-SB-681323, 7.5 mg, 24 h | 10 | 12 |
| Total, other adverse events | Cohort 3-SB-681323, 7.5 mg, 4 h | 16 | 18 |
| Total, other adverse events | Cohort 4-SB-681323, 10 mg, 24 h | 14 | 18 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26102252 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00996840
GET https://conductscience.org/api/trials/v1/NCT00996840/registered?page=2