Pain, Postoperative
Conditions
Keywords
Abdominoplasty, Pain, Transdermal, DMTS
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.
Interventions
DRUGDMTS Patch
DMTS applied before surgery and worn for 96 hours
DRUGPlacebo Patch
Matching patches that have no active drug applied before surgery and worn for 96 hours
Sponsors
Teikoku Pharma USA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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
Intervention model description
Subjects will be randomized in 1:1 ratio to receive DMTS or matching placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed