Phase 2
Completed N=45
Evaluation of DEX-IN During Outpatient Procedures
Source: ClinicalTrials.gov NCT03348423 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Evaluation of Pain Intensity - Mean Pain Score During Procedure — 3.03; 3.10; 4.25 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of Pain Intensity - Mean Pain Score During Procedure |
3.03; 3.10; 4.25 | — |
Eligibility Criteria
Inclusion Criteria
- Voluntarily provide written informed consent
- Be planned to undergo a selected office-based or outpatient procedure
- Be naïve to the planned procedure, i.e. no repeated or revision procedures
- Not pregnant or planning to become pregnant, or using appropriate contraceptive measures.
Exclusion Criteria
- Known allergy to any study treatment or excipient
- Have another painful physical condition or anxiety related diagnosis that may confound study assessments
- Evidence of a clinically significant finding on physical examination, laboratory assessment, or ECG
- Have signs or a history of significant nasal condition that may interfere with intranasal drug delivery
Data sourced from ClinicalTrials.gov (NCT03348423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.