A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Elective Unilateral Total Knee Replacement

Summary

The purpose of this study is to evaluate three different dosage strengths of sublingual ARX-F01 (Sufentanil NanoTab) versus a sublingual Placebo NanoTab for the treatment of post-operative pain in subjects following total knee replacement surgery. We hypothesize that subjects receiving placebo will have poor pain relief and will drop out of the study sooner and more often than the ARX-F01-treated subjects.

Timeline

Start

2008-03

Primary completion

2008-10

Completion

2008-10

Outcome

Met primary endpoint

registry Sufentanil NanoTab 15 Mcg vs Placebo NanoTab; p = 0.018; Mean Difference (Final Values) 20.05 NCT00612534 ↗

paper greater SPID-12 scores (ie, lower pain intensity) compared with placebo were observed for sublingual sufentanil 15 µg in the knee replacement study (P < 0.05) PMID 23271030 ↗

Publications

• Results Minkowitz HS, Singla NK, Evashenk MA, Hwang SS, Chiang YK, Hamel LG, Palmer PP. Pharmacokinetics of sublingual sufentanil tablets and efficacy and safety in the management of postoperative pain. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):131-9. doi: 10.1097/AAP.0b013e3182791157.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sufentanil	Other / unclassified	5 ug	Other
Subject	Sufentanil	Other / unclassified	10 ug	Other
Subject	Sufentanil	Other / unclassified	15 ug	Other

Indications

No indication recorded.