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Evaluation of DEX-IN During Outpatient Procedures

NCT03348423 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-05-25

Study results available
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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.

Conditions

Interventions

DRUG

DEX-IN

IN Dexmedetomidine + IV placebo

DRUG

Fentanyl

IN Placebo + IV Fentanyl

DRUG

Placebo

IN Placebo + IV Placebo

Sponsors & Collaborators

  • Baudax Bio

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-15
Primary Completion
2018-01-18
Completion
2018-01-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03348423 on ClinicalTrials.gov