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

Brief Title

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

Brief Summary

The primary objective of this study is to evaluate the analgesic efficacy of DMTS, compared <br /> 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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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.