A Study for the Evaluation of the Safety, Tolerability, and Efficacy of ARX-F02 (Sufentanil NanoTab) Compared to Placebo in the Treatment of Cancer Breakthrough Pain

Summary

The purpose of this research study was to evaluate ARX-F02 (Sufentanil NanoTab) versus placebo ("sugar" pill or inactive substance) in the management of breakthrough pain in cancer patients.

Timeline

Start

2009-04

Primary completion

2010-03

Completion

2010-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); Double Blind Phase of 7 Sufentanil Tablets vs Double Blind Phase of 3 Pbo Tablets; p <0.001; Mean Difference (Final Values) 17.3; ANCOVA NCT00833040 ↗

release “The primary endpoint of time-weighted Sum of the Pain Intensity Difference over the first 30 minutes after dosing (SPID-30) was highly statistically significant for ARX-02” talphera.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sufentanil	Other / unclassified	20 ug	Other
Subject	Sufentanil	Other / unclassified	30 ug	Other
Subject	Sufentanil	Other / unclassified	40 ug	Other
Subject	Sufentanil	Other / unclassified	60 ug	Other
Subject	Sufentanil	Other / unclassified	80 ug	Other

Indications