Phase 2
N=304
Acetaminophen/Naproxen Sodium Dose Ranging Study
Pain
Bottom Line
View on ClinicalTrials.gov: NCT04447040 ↗Enrolled (actual)
304
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Time Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12) — 5.59; 37.08; 46.98; 52.45 Units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Acetaminophen/naproxen sodium Dose A (Drug); Acetaminophen/naproxen sodium Dose B (Drug); Acetaminophen/naproxen sodium Dose C (Drug); Acetaminophen/naproxen sodium Dose D (Drug); Acetaminophen/naproxen sodium Dose E (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 17+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12) |
5.59; 37.08; 46.98; 52.45; 59.63; 65.52 | <0.001 sig |
| SECONDARY Time Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12) |
18.40; 54.06; 67.45; 72.04; 79.33; 85.98 | <0.001 sig |
| SECONDARY Time Weighted Sum of Pain Intensity Difference Score From 6 Hours to 12 Hours (SPID 6-12) |
2.58; 15.12; 20.31; 24.47; 27.59; 31.89 | <0.001 sig |
| SECONDARY Time to First Use of Rescue Analgesic Medication |
90.0; 898.0; 1195.0; NA; NA; NA | <0.001 sig |
| SECONDARY Proportion of Participants Who Required Rescue Analgesic Medication |
0.792; 0.571; 0.519; 0.353; 0.353; 0.152 | 0.014 sig |
Summary
Study assessing the relative efficacy of five strengths of a fixed combination of acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s) for further development and to evaluate the safety of a fixed combination of naproxen sodium and acetaminophen.
Eligibility Criteria
Inclusion Criteria
- Males or females 17-50 years old
- Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5-35.4 (inclusive) at screening
- Surgical removal of three or four third molars, of which, two must be mandibular impactions
- Meets requirements for post-surgical pain level
- 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 become 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, oxycodone or other opioids;
- Not able to swallow whole 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, or substance abuse, as judged by the investigator site staff, in the last 5 years
- Use of any immunosuppressive drugs within 2 weeks of screening
- History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years
Data sourced from ClinicalTrials.gov (NCT04447040). 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.