Efficacy, Tolerability, Safety, and Pharmacokinetic Study of DFN-15

Summary

Efficacy, Tolerability, Safety and Pharmacokinetic Study of DFN-15 in Post-Surgical Dental Pain.

Timeline

Start

2018-06-19

Primary completion

2018-08-20

Completion

2018-08-20

Outcome

Met primary endpoint

paper All 3 doses of DFN-15 were significantly superior to placebo in SPID6 PMID 34252915 ↗

registry p <0.0001; ANCOVA; note: p-value for each dose group vs placebo comparison NCT03554772 ↗

Publications

• Singla N, Bertoch T, Shenoy S, Munjal S. Efficacy and safety of single-dose DFN-15 for treatment of acute postsurgical dental pain: a randomized, double-blind, placebo-controlled study. Pain. 2022 Jan 1;163(1):91-99. doi: 10.1097/j.pain.0000000000002312.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DFN-15	Unknown	62.5 mg	Oral
Subject	DFN-15	Unknown	125 mg	Oral
Subject	DFN-15	Unknown	250 mg	Oral

Indications

No indication recorded.