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Evaluation of the efficacy and safety of a single dose of an ibuprofen effervescent tablet in the treatment of pain following third molar extraction in comparison to single doses of placebo, standard ibuprofen tablets, and effervescent aspirin plus vitamin C tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
| |
| 3 | Active Comparator |
| |
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| effervescent ibuprofen tablets | Drug |
| ||
| effervescent Aspirin plus Vitamin C tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of pain relief and pain intensity difference scores | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to meaningful pain relief | 8 hours |
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Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin | Texas | 78705 | United States |
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| Drug |
|
| ibuprofen tablets | Drug |
|
| placebo | Drug |
|
| ID | Term |
|---|---|
| D010146 | Pain |
| D014098 | Toothache |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
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