Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty

Pain, Postoperative Clinical Trial

— DMT2111  

Official title:

A Double-Blind, Placebo-Controlled Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05412992
• Other study ID #: TPU-DMT-02-2111
• Status: Recruiting
• Phase: Phase 2
• Start date: July 6, 2022
• Est. completion date: November 2022

Study information

• Verified date: July 2022
• Source: Teikoku Pharma USA, Inc.
• Contact: James Song, MS, MA
• Phone: 408-501-1821
• Email: jsong[@]teikokuusa.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the analgesic efficacy of DMTS, compared with placebo, in subjects following abdominoplasty.

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 information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• DMTS Patch
DMTS applied before surgery and worn for 96 hours
• Placebo Patch
Matching patches that have no active drug applied before surgery and worn for 96 hours

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	JBR Clinical Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Teikoku Pharma USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 to 96 hours following surgery
Secondary	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	5 to 96 hours following surgery
Secondary	Rescue Medication	The proportion of subjects using rescue analgesic medication	Up to 96 hours post surgery
Secondary	Rescue Medication units	Total dose of rescue analgesic medication (in morphine-equivalent units)	Up to 96 hours post surgery
Secondary	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	Up to 96 hours post surgery