NCT00859313

An Open-Label Functionality, Safety and Efficacy Study in Patients Undergoing Elective Unilateral Knee Replacement

An Open-Label Functionality, Safety, and Efficacy Study of the NanoTab® Delivery System/ARX-F01 15 Mcg in Patients Undergoing Elective Unilateral Knee Replacement

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Talphera, Inc · Industry
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study is being performed to evaluate the functionality of a device (Sufentanil NanoTab® PCA System) that has been developed for use by patients to self-administer the ARX-F01 pain medication (Sufentanil NanoTab 15 mcg) for the treatment of post-operative pain after undergoing knee replacement surgery. Another goal of this study is to assess the safety and effectiveness of this non-invasive, sublingual route of administration of ARX-F01 in decreasing the amount of pain that a patient experiences following knee replacement surgery.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Sufentanil NanoTab PCA System/15 mcg	15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-03-11
• Last updated: 2012-03-01
• Results posted: 2012-02-27

Locations

3 sites across 1 country: United States