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Evaluating Efficacy of the Dexmedetomidine Transdermal System for Postoperative Analgesia Following Abdominoplasty

Pain, Postoperative Clinical Trial

Official title:
A Double-Blind, Placebo-Controlled Evaluation of the Dexmedetomidine Transdermal System for Postoperative Analgesia Following Abdominoplasty

Clinical Trial Summary

The primary objective of this study is to evaluate the analgesic efficacy of Dexmedetomidine Transdermal System (DMTS), compared with placebo, in participants following abdominoplasty.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, one-time application study of DMTS or matching placebo over a 4-day treatment period.

Eligible subjects will be randomized in 1:1 ratio to receive DMTS or matching placebo. Subjects will reside at the clinical study unit for up to a total of 7 days. The surgical procedure, the intraoperative anesthesia, and the medication used for infiltration of the wound for local anesthesia before the last stitch will be standardized. During the postoperative period in the clinical study unit, recovery procedures will be standardized. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04242407
Study type Interventional
Source Teikoku Pharma USA, Inc.
Contact James Song, MS, MBA
Phone 408-501-1800
Email jsong@teikokuusa.com
Status Recruiting
Phase Phase 2
Start date July 7, 2020
Completion date February 1, 2021
View Details
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