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Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty — DMT2111  

Pain, Postoperative Clinical Trial

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

Clinical Trial Summary

The primary objective of this study is to evaluate the analgesic efficacy of DMTS, compared with placebo, in subjects 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 (Day 1 Time 0 occurs when the DMTS or matching placebo systems have been applied). Subjects scheduled for an abdominoplasty will be screened up to 28 days prior to surgery. Eligible subjects will be randomized equally to treatment with DMTS or matching placebo. An independent safety monitoring committee will periodically review unblinded safety data to confirm the safety/tolerability of the dose or recommend a dose reduction. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05412992
Study type Interventional
Source Teikoku Pharma USA, Inc.
Contact James Song, MS, MA
Phone 408-501-1821
Email jsong@teikokuusa.com
Status Recruiting
Phase Phase 2
Start date July 6, 2022
Completion date November 2022
View Details
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