At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 168 enrolled
Drug / intervention
Intranasal Dexmedetomidine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Efficacy and Safety of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy
In Brief
A Phase 2 clinical trial evaluating Intranasal Dexmedetomidine and Intranasal Placebo for Pain, Post-operative. Completed, enrolled 168 participants across 3 sites.
Detailed Summary
The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative Day (POD) 1, 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Post-operative
CountriesUnited States
CollaboratorsLotus Clinical Research, LLC
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
First PostedNov 2014
Primary CompletionJun 2015
TodayJul 2026
First PostedNov 5, 2014
Enrollment StartOct 1, 2014
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.7 years ago
Interventions
Intranasal Dexmedetomidinedrug
Intranasal Placebodrug