NCT00894699

A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction Procedure

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTabs™ in Patients Undergoing an Elective Abdominal Liposuction Procedure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Talphera, Inc · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of a study medication that contains a combination of a pain medication, sufentanil, and a sedative, triazolam. This drug is being designed to provide mild sedation as well as reduce anxiety and pain before and during a procedure (in this case elective abdominal liposuction).

Conditions

• Sedation
• Anxiety
• Pain

Interventions

Type	Name	Description
DRUG	Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03)	Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
DRUG	Placebo NanoTab™	Single dose of sublingual placebo NanoTab™

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2009-05-07
• Last updated: 2014-06-25
• Results posted: 2014-06-25

Locations

1 site across 1 country: United States