drugset / Trial / NCT02169336

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

NCT02169336

Phase 2 Terminated 95 enrolled Baudax Bio Lotus Clinical Research, LLC · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2014-06
Primary completion
2014-09
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 35 ug Intranasal
Subject Dexmedetomidine Other / unclassified 50 ug Intranasal

Indications