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| ID | Type | Description | Link |
|---|---|---|---|
| C4411008 | Other Identifier | Alias Study Number |
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This is a Phase 2 study designed to test the ability of investigational study drug ARRY-371797 to reduce pain either perioperatively or postoperatively in a third molar extraction pain model, and to further evaluate the drug's safety. Approximately 150 subjects from the US will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARRY-371797 | Experimental |
| |
| Placebo, ARRY-371797 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARRY-371797, p38 inhibitor; oral | Drug | dose 1, dose 2 |
| |
| Placebo; oral |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of the study drug dosed either perioperatively or postoperatively in terms of total pain relief (TOTPAR) and total pain intensity (visual analog scale, VAS). | 6 hours post dose 2 | |
| Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs. | Duration of study |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the efficacy of the study drug dosed perioperatively versus postoperatively in terms of total pain intensity (VAS). | Duration of study |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SCIREX Research Center | San Marcos | Texas | 78666 | United States | ||
| SCIREX Research Center |
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D014098 | Toothache |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C000592910 | ARRY-371797 |
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| Drug |
dose 1, dose 2 |
|
| Placebo; oral | Drug | dose 1 |
|
| ARRY-371797, p38 inhibitor; oral | Drug | dose 2 |
|
| Salt Lake City |
| Utah |
| 84117 |
| United States |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |