Phase 3
Completed N=501
Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain
Post-operative Dental Pain
Source: ClinicalTrials.gov NCT03566979 ↗
Enrolled (actual)
501
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Time to Confirmed Perceptible Pain Relief — NA; 18.7; 23.5; 28.1 Minutes
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets compared with two commercial naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg liquid gels capsules) and placebo in the dental pain model following third-molar extractions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Confirmed Perceptible Pain Relief |
NA; 18.7; 23.5; 28.1 | — |
| SECONDARY Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments |
27.6; 84.9; 25.9; 84.9; 25.9; 84.2 | — |
Eligibility Criteria
Inclusion Criteria
- 17 - 50 years old
- Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening
- Dental extraction of three or four third molars
- Meets post-surgical pain
- Females of childbearing potential and males agree to contraceptive requirements of study
- Have a negative urine drug screen at screening, and on day of surgical procedure
Exclusion Criteria
- Pregnant female, breastfeeding, trying to be pregnant or male with pregnant partner or partner currently trying to become pregnant
- Have a known allergy or hypersensitivity to naproxen or other NSAIDs, including aspirin, or to acetaminophen, hydrocodone or other opioids
- Not able to swallow large tablets or capsules
- History of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
- Use analgesics 5 or more times per week
- History of chronic tranquilizer use, heavy drinking, substance abuse as judged by investigator site staff within last 5 years
- Use of immunosuppressive drugs within 2 weeks of screening
- History of endoscopically documented peptic ulcer disease or bleeding disorder in last 2 years
Data sourced from ClinicalTrials.gov (NCT03566979). 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. Informational only — not medical advice.