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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03348423
Other study ID # REC-17-023
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 15, 2017
Est. completion date January 18, 2018

Study information

Verified date April 2023
Source Baudax Bio
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date January 18, 2018
Est. primary completion date January 18, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
DEX-IN
IN Dexmedetomidine + IV placebo
Fentanyl
IN Placebo + IV Fentanyl
Placebo
IN Placebo + IV Placebo

Locations

Country Name City State
United States Research Center Pasadena California

Sponsors (1)

Lead Sponsor Collaborator
Baudax Bio

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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