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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005278-12 | EudraCT Number |
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The objective of the study is to evaluate the analgesic efficacy of a single, oral dose of fast release aspirin tablets, 650 mg (2 x 325 mg) compared to regular aspirin tablets, 650 mg (2 x 325 mg) and placebo in subjects with postsurgical dental pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
| |
| Arm 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036) | Drug | Single dose of fast acting aspirin 2 x 325 mg = 650 mg total |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Perceptible Pain Relief (PR) | 0 to 6 hours | |
| Time to First Perceptible Pain Relief Confirmed | 0 to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to meaningful pain relief | 0 to 6 hours | |
| Pain Intensity at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing | 10, 20, 30, 40, and 50 minutes and at 1, 2, 3, 4, 5, and 6 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin | Texas | 78705 | United States | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Acetylsalicyclic acid (Aspirin, BAYE4465) | Drug | Single dose of regular aspirin 2 x 325 mg = 650 mg total |
|
| Placebo | Drug | Two placebo tablets |
|
| Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing | 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours post-dose |
| Pain Relief at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing | 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours post-dose |
| Summed Pain Intensity Differences (SPID ) from Hour 0 through Hour 2, Hour 4 and Hour 6 | 0 - 6 hours post-dose |
| Summed Total Pain Relief (TOTPAR ) from Hour 0 through Hour 2, Hour 4 and Hour 6 | 0-6 hours post-dose |
| Time to First use of Rescue Medication | 0 to 6 hours |
| Cumulative Percentage of Subjects Taking Rescue Medication | 1, 2, 3, 4, 5, and 6 hours post-dose |
| Global Assessment of the Investigational Product as a Pain Reliever at 6 hours After Dosing or Immediately Before the First Intake of Rescue Medication | At 6 hours postdose or immediately before first use of rescue medication |
| Salt Lake City |
| Utah |
| 84124 |
| United States |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |