NCT00612534

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Talphera, Inc · Industry
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
DRUG	Sufentanil NanoTab	5 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
DRUG	Placebo NanoTab	Placebo NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
DRUG	Sufentanil NanoTab	10 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
DRUG	Sufentanil NanoTab	15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-02-11
• Last updated: 2014-02-17
• Results posted: 2014-02-17

Locations

1 site across 1 country: United States