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| ID | Type | Description | Link |
|---|---|---|---|
| C4411009 | 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 in a postoperative pain model (third molar extraction), and to further evaluate the drug's safety. Approximately 250 subjects from the US will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Placebo, ARRY-371797 | Experimental |
| |
| ARRY-371797, Placebo | Experimental |
| |
| ARRY-371797 | Experimental |
| |
| Celecoxib, Placebo | Active Comparator |
| |
| Celecoxib, ARRY-371797 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo; oral | Drug | dose 1, dose 2 |
| |
| Placebo; oral |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of the study drug dosed postoperatively in terms of total pain relief (TOTPAR). | 6 hours post-dose | |
| 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 |
|---|---|---|
| Assess the efficacy of the study drug (versus placebo and celecoxib) in terms of pain relief measurements [including TOTPAR, total pain intensity (TPI) and time to rescue medication]. | 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 |
|---|---|---|---|---|---|---|
| PPD Phase I Clinic | Austin | Texas | 78744 | United States | ||
| Lifetree Clinical Research |
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 |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C000592910 | ARRY-371797 |
| D000068579 | Celecoxib |
| D052246 | Cyclooxygenase 2 Inhibitors |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Drug |
dose 1 |
|
| ARRY-371797, p38 inhibitor; oral | Drug | dose 1: multiple dose levels |
|
| ARRY-371797, p38 inhibitor; oral | Drug | dose 1: multiple dose levels; dose 2 |
|
| Celecoxib, COX-2 inhibitor; oral | Drug | dose 1 |
|
| Placebo; oral | Drug | dose 2 |
|
| ARRY-371797, p38 inhibitor; oral | Drug | dose 2 |
|
| Salt Lake City |
| Utah |
| 84106 |
| United States |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D016861 | Cyclooxygenase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |