Study to Collect Information on How Well the Study Drug Naproxen Sodium Tablets Works Compared to Hydrocodone/Acetaminophen Tablets in Order to Relieve Pain in Participants Experiencing Moderate to Severe Pain After Having Their Wisdom Teeth Removed

Summary

With this study researchers want to collect information on how long the pain relief lasts after a fixed dose of naproxen sodium or hydrocodone/acetaminophen or placebo (contains no medication) over 12 hours in subjects experiencing moderate to severe pain after having their wisdom teeth removed. Naproxen Sodium (Aleve®) is a drug that is used for the temporary relief of minor aches and pains. Hydrocodone/Acetaminophen is a combination drug used to relieve moderate to severe pain. It contains an opioid (narcotic) pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).

Timeline

Start

2020-03-12

Primary completion

2020-10-02

Completion

2020-10-05

Outcome

Met primary endpoint

registry analysis (superiority test); Naproxen Sodium vs Hydrocodone / APAP; p = 0.001; LS Mean Difference 14.81 (95% CI 6.10 to 23.51); NCT04307940 ↗

paper NapS was significantly more effective than HYD+APAP regarding SPID0-12 (p = 0.01; primary endpoint), PMID 34878953 ↗

Publications

• Cooper SA, Desjardins PJ, Bertoch T, Paredes-Diaz A, Troullos E, Tajaddini A, Centofanti R, An R, Morella D. Analgesic efficacy of naproxen sodium versus hydrocodone/acetaminophen in acute postsurgical dental pain: a randomized, double-blind, placebo-controlled trial. Postgrad Med. 2022 Jun;134(5):463-470. doi: 10.1080/00325481.2021.2008180. Epub 2021 Dec 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Acetaminophen	Small molecule	650 mg	Oral
Comparator	Hydrocodone	Unknown	10 mg	Oral
Subject	Naproxen	Small molecule	440 mg	Oral

Indications

No indication recorded.