A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine

NCT02209181 ↗

Phase 2 Completed 269 enrolled McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To assess the safety and effectiveness one dose of a new pain reliever medicine (JNJ-10450232 at either the 250 or 1000 mg strength) compared with placebo (sugar pill) or acetaminophen 1000 mg after surgical removal of third molars. The primary endpoint will evaluate pain relief effectiveness up to 6 hours after administration of the study drug.

Timeline

Start: 2014-08
Primary completion: 2015-04
Completion: 2015-04

Publications

Gelotte CK, Vakil AM, Zimmerman BA, Zannikos P, Mishra R, Eichenbaum G, Kuffner EK, Flores CM. JNJ-10450232 (NTM-006), A novel non-opioid with structural similarities to acetaminophen, produces relatively long-lasting analgesia after a single dose in patients undergoing 3rd molar extraction. Regul Toxicol Pharmacol. 2025 Sep;161 Suppl 1:105480. doi: 10.1016/j.yrtph.2023.105480. Epub 2023 Aug 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Acetaminophen	Small molecule	1000 mg	—
Comparator	JNJ-10450232	Small molecule	250 mg	—
Comparator	JNJ-10450232	Small molecule	1000 mg	—

Indications

No indication recorded.