At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 45 enrolled
Drug / intervention
DEX-IN +2 moredrug
Likely dose
Dexmedetomidine intranasal (DEX-IN) dose not specified; Fentanyl IV dose not specifiedAI-extracted
Key inclusion· 3
- ✓Planned to undergo a selected office-based or outpatient procedure
- ✓Naïve to the planned procedure (no prior or revision procedures)
- ✓Able to provide written informed consent
Key exclusion· 4
- ✕Known allergy to any study treatment or excipient
- ✕Another painful physical condition or anxiety-related diagnosis that may confound study assessments
- ✕Evidence of clinically significant finding on physical examination, laboratory assessment, or ECG
- ✕Signs or history of significant nasal condition that may interfere with intranasal drug delivery
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Evaluation of the Efficacy and Safety of DEX-IN Following Painful Outpatient Procedures
In Brief
A Phase 2 clinical trial evaluating DEX-IN, Fentanyl, and 1 other intervention for Pain. Completed, enrolled 45 participants across 1 site.
Detailed Summary
The primary objective of this study is to evaluate the analgesic efficacy of DEX-IN compared with placebo and active control (fentanyl), in subjects undergoing painful outpatient and office based procedures.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartNov 2017
First PostedNov 2017
Primary CompletionJan 2018
TodayJul 2026
First PostedNov 20, 2017
Enrollment StartNov 15, 2017
Primary CompletionJan 18, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.6 years ago
Interventions
DEX-INdrug
IN Dexmedetomidine + IV placebo
Fentanyldrug
IN Placebo + IV Fentanyl
Placebodrug
IN Placebo + IV Placebo