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

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

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

Study Overview

• Status: Terminated
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: DMTS Patch; Drug: Placebo Patch

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.

• Study Type: Interventional
• Enrollment (Actual): 179
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • JBR Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, ≥ 18 years of age.
• Scheduled to undergo a full abdominoplasty (including repair of small incidental abdominal hernias, but not including liposuction).
• Have a physical status classification of 1 or 2 per the American Society of Anesthesiology.
• Have a body weight > 58 kg, and body mass index of 20 to 38 kg/m2, inclusive.

Exclusion Criteria:

• Known sensitivity to dexmedetomidine or any excipient in the DMTS/placebo or to any peri- or postoperative medication whose use is required in this study.
• Skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS/matching placebo application site, according to examination by the investigator at screening or admission to the clinic prior to surgery.
• History of deep vein thrombosis or factor V Leiden deficiency.
• History of syncope or other syncopal attacks.
• Present and/or significant history of postural hypotension (determined through examination by the investigator or designee), or history of severe dizziness or fainting on standing in the opinion of the investigator.
• Evidence of a clinically significant 12-lead ECG abnormality.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DMTS Patch; DMTS applied to upper outer arm	Drug: DMTS Patch; DMTS applied before surgery and worn for 96 hours; Other Names: DMTS
Placebo Comparator: Placebo Patch; Placebo system (with no drug) to match DMTS applied to the upper arm	Drug: Placebo Patch; Matching patches that have no active drug applied before surgery and worn for 96 hours; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-interval weighted summed pain intensity (SPI) at designated time points	The SPI measured using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain	5 to 96 hours following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-interval weighted summed pain intensity (SPI) over various time intervals	The SPI measured using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain, measured at rest over various time intervals	5 to 96 hours following surgery
Rescue Medication	The proportion of subjects using rescue analgesic medication	Up to 96 hours post surgery
Rescue Medication units	Total dose of rescue analgesic medication (in morphine-equivalent units)	Up to 96 hours post surgery
Integrated Pain score and Rescue Medication	Integrated assessment of summed pain intensity (SPI) using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain, at the time Rescue Medication was administered	Up to 96 hours post surgery

Collaborators and Investigators

• Sponsor: Teikoku Pharma USA, Inc.
• Investigators: Study Director: James Song, MS, MA, Teikoku Pharma USA, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Actual): April 19, 2023
• Study Completion (Actual): April 19, 2023

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Transdermal; Abdominoplasty; DMTS
• Additional Relevant MeSH Terms: Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Pain, Postoperative
• Other Study ID Numbers: TPU-DMT-02-2111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan is in place to share individual participant data at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No