NCT04242407

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (estimated)
• 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 Dexmedetomidine Transdermal System (DMTS), compared with placebo, in participants 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. 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.

Conditions

• Pain, Postoperative

Interventions

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

Timeline

• Start date: 2020-07-07
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2020-01-27
• Last updated: 2020-07-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study