Status:
COMPLETED
Evaluation of DEX-IN During Outpatient Procedures
Lead Sponsor:
Baudax Bio
Conditions:
Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 proc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2018
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03348423
Start Date
November 15 2017
End Date
January 18 2018
Last Update
May 25 2023
Active Locations (1)
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1
Research Center
Pasadena, California, United States, 91105