Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty (DMT2111)

Teikoku Pharma

Status and phase: Enrolling; Phase 2

Conditions: Pain, Postoperative

Treatments: Drug: Placebo Patch; Drug: DMTS Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT05412992

TPU-DMT-02-2111

Details and patient eligibility

About

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

Full 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.

Enrollment: 182 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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182 participants in 2 patient groups, including a placebo group

DMTS Patch

Active Comparator group

Description:

DMTS applied to upper outer arm

Treatment:

Drug: DMTS Patch

Placebo Patch

Placebo Comparator group

Description:

Placebo system (with no drug) to match DMTS applied to the upper arm

Treatment:

Drug: Placebo Patch