Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty

NCT05412992 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: TPU-DMT-02-2111
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pain, Postoperative

Keywords

Abdominoplasty; Pain; Transdermal; DMTS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time-interval weighted summed pain intensity (SPI) over various time intervals

  5 to 96 hours following surgery

• Rescue Medication

  Up to 96 hours post surgery

• Rescue Medication units

  Up to 96 hours post surgery

• Integrated Pain score and Rescue Medication

  Up to 96 hours post surgery

Study Arms (2)

DMTS Patch

ACTIVE COMPARATOR

DMTS applied to upper outer arm

Drug: DMTS Patch

Placebo Patch

PLACEBO COMPARATOR

Placebo system (with no drug) to match DMTS applied to the upper arm

Drug: Placebo Patch

Interventions

DMTS Patch DRUG

DMTS applied before surgery and worn for 96 hours

Also known as: DMTS

DMTS Patch

Placebo Patch DRUG

Matching patches that have no active drug applied before surgery and worn for 96 hours

Also known as: Placebo

Placebo Patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teikoku Pharma USA, Inc.: lead

Study Sites (2)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• James Song, MS, MA

  Teikoku Pharma USA, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The sponsor, the investigator, personnel at the clinical study unit who are directly involved with monitoring and/or performing study procedures and assessments, and the subjects will be blinded to treatment assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized in 1:1 ratio to receive DMTS or matching placebo

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 9, 2022
• Study Start: July 7, 2022
• Primary Completion: April 19, 2023
• Study Completion: April 19, 2023
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)