NCT05412992

Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 179 (actual)
• Sponsor: Teikoku Pharma USA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the analgesic efficacy of DMTS, compared with placebo, in subjects following abdominoplasty.

Detailed 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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	DMTS Patch	DMTS applied before surgery and worn for 96 hours
DRUG	Placebo Patch	Matching patches that have no active drug applied before surgery and worn for 96 hours

Timeline

• Start date: 2022-07-07
• Primary completion: 2023-04-19
• Completion: 2023-04-19
• First posted: 2022-06-09
• Last updated: 2025-12-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study