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

Pain, Postoperative Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00859313
Study type Interventional
Source AcelRx Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 2
Start date April 2009
Completion date August 2009
View Details
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