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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005271-81 | 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, 1000 mg (2 x 500 mg) compared to regular aspirin tablets, 1000 mg (2 x 500 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylic acid (Fast release Aspirin, BAY1019036) | Drug | Single oral dose of fast release aspirin tablets 1000 mg (2 x 500 mg) with a full glass of water (240 milliliter [mL]) between 14 hours post dental surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Perceptible Pain Relief (PR) | 0 to 6 hours | |
| Time to First Perceptible Pain Relief (PR) Confirmed | 0 to 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Meaningful Pain Relief (PR) | 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 | Pain Intensity (PI) was rated by subjects on a 4-point Categorical Pain Intensity Scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain) for all pain intensity assessments 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 | 78744 | 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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| Acetylsalicylic Acid (Aspirin, BAYE4465) | Drug | Single oral dose of regular aspirin tablet 1000 mg (2 x 500 mg) with a full glass of water (240 mL) between 14 hours post dental surgery. |
|
| Placebo | Drug | Single oral dose of 2 placebo tablets with a full glass of water (240 mL) between 14 hours post dental surgery. |
|
| 10, 20, 30, 40, and 50 minutes and at 1, 2, 3, 4, 5, and 6 hours postdose |
| Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 Minutes and at 2, 3, 4, 5, and 6 Hours After Dosing | Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain) for all pain intensity assessments post-dose. For each post-dose time point, PID was derived by subtracting the pain intensity at the post-dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. | 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours postdose |
| Pain Relief at 10, 20, 30, 40, 50, and 60 Minutes and at 2, 3, 4, 5, and 6 Hours After Dosing | Pain relief was rated by subjects using a 5-point Categorical Relief Rating Scale (0 = no relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). | 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours postdose |
| Summed Pain Intensity Differences (SPID) From Hour 0 Through Hour 2, Hour 4 and Hour 6 | 0 to 6 hours postdose |
| 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 postdose |
| 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 |
| 84106 |
| United States |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |