A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain, Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery, Musculoskeletal |
| Healthy: | No |
| Age Range: | 16 - 40 |
| Updated: | 8/5/2018 |
| Start Date: | February 12, 2018 |
| End Date: | July 6, 2018 |
A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain
To compare the duration of analgesic efficacy as determined by the time to rescue medication
of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen
400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to
severe post-impaction surgery dental pain.
To compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440
mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
To compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440
mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen
400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to
severe post-impaction surgery dental pain.
To compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440
mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
To compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440
mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
Inclusion Criteria:
- Healthy, ambulatory, male or female volunteers 16-40 years of age;
- Body mass index 18.0 to 30.0 kg/m2 inclusive;
- Scheduled to undergo surgical removal of at least 2 mandibular partial or full bony
impacted third molars. Up to two maxillary third molars may be removed regardless of
impaction level. Supernumerary teeth present may also be removed at the discretion of
the oral surgeon;
- Mandibular molars must demonstrate modified Demirjian root classification stage D, E,
F, G or H;
Exclusion Criteria:
- History of hypersensitivity to naproxen sodium, ibuprofen, NSAIDS, aspirin, similar
pharmacological agents, local anesthetics, rescue medication or components of the
investigational products;
- Evidence or history of clinically significant (in the judgment of the investigator)
hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic,
psychiatric, neurologic diseases, or malignancies within the last 5 years;
- Relevant concomitant disease such as asthma (exercise induced asthma is permitted)
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