Evaluation of DEX-IN During Outpatient Procedures
- Registration Number
- NCT03348423
- Lead Sponsor
- Baudax Bio
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo DEX-IN 50 µg DEX-IN Dexmedetomidine Intranasal Spray Fentanyl 50 µg Fentanyl Intravenous Fentanyl
- Primary Outcome Measures
Name Time Method Evaluation of Pain Intensity - Mean Pain Score During Procedure Up to 4 Hours Evaluation of subject reported pain intensity scores according to the 11-point Numeric Pain Rating Scale (NPRS; 0-10)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Center
🇺🇸Pasadena, California, United States