A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery

Summary

The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of moderate-to-severe acute post-operative pain in patients after abdominal surgery.

Timeline

Start

2015-02

Primary completion

2015-06

Completion

2015-08

Outcome

Met primary endpoint

release “ARX-04 (sufentanil sublingual tablet, 30 mcg) met primary and secondary endpoints in a multi-center, double-blind, placebo-controlled Phase 3 trial (SAP301)” talphera.com ↗

release “met primary and secondary endpoints in a multi-center, double-blind, placebo-controlled Phase 3 trial (SAP301)” talphera.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sufentanil	Other / unclassified	30 ug	Subcutaneous

Indications

No indication recorded.