Clinical trial NCT05412992: Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty
Official title: A Double-Blind, Placebo-Controlled Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pain, Postoperative
Keywords: Abdominoplasty
Pain
Transdermal
DMTS
Lead sponsor: Teikoku Pharma USA, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-09
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized in 1:1 ratio to receive DMTS or matching placebo
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time-interval weighted summed pain intensity (SPI) at designated time points
timeFrame: 5 to 96 hours following surgery
Secondary outcomes:
measure: Time-interval weighted summed pain intensity (SPI) over various time intervals
timeFrame: 5 to 96 hours following surgery
measure: Rescue Medication
timeFrame: Up to 96 hours post surgery
measure: Rescue Medication units
timeFrame: Up to 96 hours post surgery
measure: Integrated Pain score and Rescue Medication
timeFrame: Up to 96 hours post surgery
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
Study officials:
affiliation: Teikoku Pharma USA, Inc.
name: James Song, MS, MA
role: STUDY_DIRECTOR
References: