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Terminated early due to administrative reasons not related to safety.
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The primary objective of this study is to assess the analgesic properties of an oral dose of V117957 4.5 mg aqueous suspension in the third molar extraction model
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V117957 | Experimental |
| |
| Ibuprofen | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V117957 | Drug | V117957 4.5 mg suspension taken orally after surgery. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total pain relief 0 to 8 hours after dosing (TOTPAR8) | Time-weighted sum of pain relief scores 0 to 8 hours after dosing | 0 - 8 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Total Pain Relief 0 - 4 hours after dosing (TOTPAR4) | Hour 4 postdose | |
| Total Pain Relief 0 - 6 hours after dosing (TOTPAR6) | Hour 6 postdose | |
| Total Pain Relief 0 - 12 hours after dosing (TOTPAR12) |
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Inclusion Criteria include:
Exclusion Criteria include:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Dental Pain Clinic | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Ibuprofen |
| Drug |
Ibuprofen 400 mg tablets taken orally after surgery. |
|
| Placebo | Drug | Placebo taken orally after surgery. |
|
| Hour 12 postdose |
| Total Pain Relief 0 - 24 hours after dosing (TOTPAR24) | Hour 24 postdose |
| Pain Relief (PR) over time | Up to 24 hours postdose |
| Pain intensity difference over time | 15, 30, 45 , 60, 90 minutes; 2, 3, 4, 4.5, 6, 8, 10, 12 and 24 hours postdose |
| Sum of pain intensity difference 0 to 4 hours after dosing (SPID4) | Hour 4 postdose |
| Sum of pain intensity difference 0 to 6 hours after dosing (SPID6) | Hour 6 postdose |
| Sum of pain intensity difference 0 to 8 hours after dosing (SPID8) | Hour 8 postdose |
| Sum of pain intensity difference 0 to 12 hours after dosing (SPID12) | Hour 12 postdose |
| Sum of pain intensity difference 0 to 24 hours after dosing (SPID24) | Hour 24 postdose |
| Time to first perceptible PR | Up to 24 hours postdose |
| Time to meaningful PR | Up to 24 hours postdose |
| Time to first use of rescue pain medication | Up to 24 hours postdose |
| Proportion of subjects taking rescue medication by time point | Up to 24 hours postdose |
| Global assessment of overall satisfaction | Hour 24 postdose |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |