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This study will assess the safety and efficacy of lumiracoxib 400 mg in relieving moderate to severe post-dental surgery pain, compared to both placebo and celecoxib 400 mg.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumiracoxib | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Superiority of a single dose of lumiracoxib 400 mg compared to placebo and celecoxib 400 mg based on a Summed (time weighted) Pain Intensity Difference calculated over 0-8 hours post-dose (SPID-8) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate efficacy of a single dose of lumiracoxib 400 mg compared to placebo and to celecoxib 400 mg in relieving post dental surgery pain with respect to the following secondary efficacy variables: | ||
| Time-specific Pain intensity Difference (PID) based on the categorical scale, Pain Relief (PR) based on the categorical scale, and Pain Relief Intensity Difference (PRID) (sum of PID and PR based on categorical scales) at time-points up to 24 hours after |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental Research Clinic | Austin | Texas | 78703 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17933588 | Result | Fricke J, Davis N, Yu V, Krammer G. Lumiracoxib 400 mg compared with celecoxib 400 mg and placebo for treating pain following dental surgery: a randomized, controlled trial. J Pain. 2008 Jan;9(1):20-7. doi: 10.1016/j.jpain.2007.08.004. Epub 2007 Oct 15. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C473384 | lumiracoxib |
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| Time-specific PID based on VAS at time-points up to 24 hours after dosing |