Phase 2
N=290
Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study
Pain
Bottom Line
View on ClinicalTrials.gov: NCT03879408 ↗Enrolled (actual)
290
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6) — 2.36; 25.59; 30.28; 33.77 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 440 mg naproxen sodium with 1000 mg acetaminophen (Drug); 220 mg naproxen sodium with 650 mg acetaminophen (Drug); 10 mg hydrocodone + 650 mg acetaminophen (Drug); 440 mg naproxen sodium (Drug); Placebo tablet (Drug)
- Age
- Pediatric, Adult · 17+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6) |
2.36; 25.59; 30.28; 33.77; 23.60 | — |
| PRIMARY Time-weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12) |
5.80; 50.07; 55.47; 66.43; 39.94 | — |
| SECONDARY Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6) |
7.96; 35.20; 40.94; 45.13; 32.88 | — |
| SECONDARY Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 8 Hours (TOTPAR 0-8) |
11.12; 47.19; 54.37; 60.78; 41.61 | — |
| SECONDARY Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12) |
18.20; 69.96; 76.80; 90.22; 57.03 | — |
| SECONDARY Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 8 Hours (SPID 0-8) |
3.24; 34.11; 39.98; 45.27; 29.58 | — |
| SECONDARY Pain Relief (PAR) Scores at Individual Timepoints |
0.45; 0.80; 1.36; 1.07; 1.04; 0.51 | — |
| SECONDARY Pain Intensity Difference (PID) Scores at Individual Time Points |
0.25; 0.58; 1.01; 0.85; 00.79; 0.07 | — |
| SECONDARY Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation |
0.8; 2.7; 2.9; 3.3; 2.7 | — |
Summary
Study assessing efficacy and safety of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and Placebo in a postoperative dental pain.
Eligibility Criteria
Inclusion Criteria
- Males of females 17-50 years old
- Weigh 100 pounds or greater and have a body mass index (BMI) of 18.5 to 35 (inclusive) at screening
- Surgical removal of up to 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 known allergy or hypersensitivity to naproxen or other NSAIDS, including aspirin, or to acetaminophen, tramadol, 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 peptic ulcer disease or gastrointestinal bleeding in the last two years or hematologic bleeding
Data sourced from ClinicalTrials.gov (NCT03879408). 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.