Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Pain, Postoperative

In brief

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

Key facts

Study ID

NCT05412992

Run by

Teikoku Pharma USA, Inc.

People needed

179

Starts

2022-07-07

Expected to finish

2023-04-19

Last updated by the study team

2025-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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