Double-Blind, Placebo-Controlled Evaluation of the DMTS

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teikoku Pharma USA, Inc.

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.