Status:
TERMINATED
Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty
Lead Sponsor:
Teikoku Pharma USA, Inc.
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 syst...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2023
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT05412992
Start Date
July 7 2022
End Date
April 19 2023
Last Update
December 24 2025
Active Locations (2)
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1
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
2
JBR Clinical Research
Salt Lake City, Utah, United States, 84107