Phase 3
N=312
Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.
Toothache
Bottom Line
View on ClinicalTrials.gov: NCT00720057 ↗Enrolled (actual)
312
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcome: Primary: Summed Pain Intensity Difference (SPID) — 25.9; -3.1; 8.8; -1.0 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Naproxen Sodium ER (BAYH6689) (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summed Pain Intensity Difference (SPID) |
25.9; -3.1; 8.8; -1.0 | <0.001 sig |
| SECONDARY Total Pain Relief (TOTPAR) |
12.7; 3.1; 25.5; 5.5; 34.1; 7.2 | <0.001 sig |
| SECONDARY Summed Pain Intensity Difference at Specific Time Intervals |
6.2; -0.4; 12.7; -1.4; 17.1; -2.0 | <0.001 sig |
| SECONDARY Time to First Use of Rescue Medication |
22.27; 1.90 | <0.001 sig |
| SECONDARY Global Assessment of the Investigational Product as a Pain Reliever |
2.3; 0.6 | <0.001 sig |
| SECONDARY Time to Onset of Effect |
1.37; 4.13 | <0.001 sig |
Summary
To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.
Eligibility Criteria
Inclusion Criteria
- Healthy, ambulatory, male and female volunteers between 16 to 45
- Scheduled to undergo surgical removal of 1 - 2 impacted third molars, one of which must be at least a partial mandibular bony impaction
- No use of any analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, any other pain reliever (Over The Counter or prescription), or herbal supplements within 5 days of surgery
- Have moderate to severe postoperative pain on the Categorical Pain Intensity Scale (a score of at least 2 on a 4 point scale) and a score of >/= 50 mm on the 100-mm visual analog Pain Severity Rating Scale
Exclusion Criteria
- History of hypersensitivity to naproxen sodium, aspirin (ASA), other NSAIDs, opioid analgesics, and similar pharmacological agents or components of the investigational products, including the placebo
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies
- Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study
- Current or past history of bleeding disorder(s)
- History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
Data sourced from ClinicalTrials.gov (NCT00720057). 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.