NCT02169336

Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Efficacy, Safety, and Pharmacokinetics of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Baudax Bio · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the analgesic efficacy of two dose levels of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute moderate to severe pain following unilateral bunionectomy.

Conditions

• Pain, Post-operative

Interventions

Type	Name	Description
DRUG	Intranasal Dexmedetomidine
OTHER	Intranasal Placebo

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-09-01
• Completion: 2014-10-01
• First posted: 2014-06-23
• Last updated: 2015-12-10
• Results posted: 2015-12-10

Locations

3 sites across 1 country: United States