Phase 4
N=387
A Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT03404206 ↗Enrolled (actual)
387
Serious AEs
0.3%
Results posted
Jul 2019
Primary outcome: Primary: Time to First Use of Rescue Medication — 1.22; 1.22; 1.18; 11.017 hours — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Naproxen Sodium (Aleve, BAY117031) (Drug); Ibuprofen (Advil) (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Use of Rescue Medication |
1.22; 1.22; 1.18; 11.017; 8.267; 2.117 | <0.001 sig |
| SECONDARY Sum of Pain Intensity Difference (SPID) |
83.29; 48.54; 9.96 | — |
| SECONDARY Total Pain Relief (TOTPAR) |
47.16; 28.96; 13.40 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Healthy, ambulatory, male or female volunteers 16-40 years of age;
- Body mass index 18.0 to 30.0 kg/m^2 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, nonsteroidal anti-inflammatory drugs (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)
Data sourced from ClinicalTrials.gov (NCT03404206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.