The primary objective of this study is to evaluate the analgesic efficacy of DMTS, compared with placebo, in subjects following abdominoplasty.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
179
DMTS applied before surgery and worn for 96 hours
Matching patches that have no active drug applied before surgery and worn for 96 hours
Anaheim Clinical Trials, LLC
Anaheim, California, United States
JBR Clinical Research
Salt Lake City, Utah, United States
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
Time frame: 5 to 96 hours following surgery
Time-interval weighted summed pain intensity (SPI) over various time intervals
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
Time frame: 5 to 96 hours following surgery
Rescue Medication
The proportion of subjects using rescue analgesic medication
Time frame: Up to 96 hours post surgery
Rescue Medication units
Total dose of rescue analgesic medication (in morphine-equivalent units)
Time frame: Up to 96 hours post surgery
Integrated Pain score and Rescue Medication
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
Time frame: Up to 96 hours post surgery
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