Evaluation of DEX-IN During Outpatient Procedures
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Evaluation of the Efficacy and Safety of DEX-IN Following Painful Outpatient Procedures
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 pain
Started Nov 2017
Shorter than P25 for phase_2 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2017
CompletedFirst Submitted
Initial submission to the registry
November 16, 2017
CompletedFirst Posted
Study publicly available on registry
November 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2018
CompletedResults Posted
Study results publicly available
May 25, 2023
CompletedMay 25, 2023
April 1, 2023
2 months
November 16, 2017
April 28, 2023
April 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of Pain Intensity - Mean Pain Score During Procedure
Evaluation of subject reported pain intensity scores according to the 11-point Numeric Pain Rating Scale (NPRS; 0-10)
Up to 4 Hours
Study Arms (3)
DEX-IN 50 µg
EXPERIMENTALDexmedetomidine Intranasal Spray
Fentanyl 50 µg
ACTIVE COMPARATORIntravenous Fentanyl
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baudax Biolead
Study Sites (1)
Research Center
Pasadena, California, 91105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Development
- Organization
- Baudax Bio, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind, double-dummy
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2017
First Posted
November 20, 2017
Study Start
November 15, 2017
Primary Completion
January 18, 2018
Study Completion
January 18, 2018
Last Updated
May 25, 2023
Results First Posted
May 25, 2023
Record last verified: 2023-04