NCT02953054

Dexmedetomidine Transdermal System (DMTS) for Post-Operative Analgesia Following Bunionectomy

A Double-Blind, Placebo-Controlled, Single-Dose Evaluation of the Dexmedetomidine Transdermal System for Post-Operative Analgesia Following Bunionectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Teikoku Pharma USA, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether the DMTS, compared with a placebo patch, will provide adequate pain relief during the first 3 days following bunionectomy surgery.

Detailed description

The primary objective of this study is to evaluate the analgesic efficacy of the DMTS, compared with placebo in subjects with acute moderate to severe pain following unilateral bunionectomy. The secondary objectives are: * To assess the safety and tolerability of the DMTS, including assessment of skin irritation * To assess adhesion of the DMTS * To assess the sedation effect of the DMTS

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	DMTS	DMTS applied before surgery and worn for 72 hours
DRUG	Placebo	Matching patches that have no active drug applied before surgery and worn for 72 hours.

Timeline

• Start date: 2017-01-22
• Primary completion: 2017-07-03
• Completion: 2017-07-03
• First posted: 2016-11-02
• Last updated: 2017-10-09

Locations

2 sites across 1 country: Australia