Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty
- Conditions
- Pain, Postoperative
- Interventions
- Drug: DMTS PatchDrug: Placebo Patch
- Registration Number
- NCT05412992
- Lead Sponsor
- Teikoku Pharma USA, Inc.
- 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 182
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DMTS Patch DMTS Patch DMTS applied to upper outer arm Placebo Patch Placebo Patch Placebo system (with no drug) to match DMTS applied to the upper arm
- Primary Outcome Measures
Name Time Method Time-interval weighted summed pain intensity (SPI) at designated time points 5 to 96 hours following surgery 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
- Secondary Outcome Measures
Name Time Method Time-interval weighted summed pain intensity (SPI) over various time intervals 5 to 96 hours following surgery 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
Rescue Medication Up to 96 hours post surgery The proportion of subjects using rescue analgesic medication
Rescue Medication units Up to 96 hours post surgery Total dose of rescue analgesic medication (in morphine-equivalent units)
Integrated Pain score and Rescue Medication Up to 96 hours post surgery 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
Trial Locations
- Locations (2)
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
JBR Clinical Research
🇺🇸Salt Lake City, Utah, United States