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Dexmedetomidine Transdermal System (DMTS) for Post-Operative Analgesia Following Bunionectomy — DMTS  

Pain, Postoperative Clinical Trial

Official title:
A Double-Blind, Placebo-Controlled, Single-Dose Evaluation of the Dexmedetomidine Transdermal System for Post-Operative Analgesia Following Bunionectomy

Clinical Trial Summary

The purpose of this study is to evaluate whether the DMTS, compared with a placebo patch, will provide adequate pain relief during the first 3 days following bunionectomy surgery.

Clinical Trial Description

The primary objective of this study is to evaluate the analgesic efficacy of the DMTS, compared with placebo in subjects with acute moderate to severe pain following unilateral bunionectomy.

The secondary objectives are:

- To assess the safety and tolerability of the DMTS, including assessment of skin irritation

- To assess adhesion of the DMTS

- To assess the sedation effect of the DMTS ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02953054
Study type Interventional
Source Teikoku Pharma USA, Inc.
Contact
Status Completed
Phase Phase 2
Start date January 22, 2017
Completion date July 3, 2017
View Details
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