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OpenTrials
Completed

NCT Number: NCT03348423

Evaluation of DEX-IN During Outpatient Procedures

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.

Completed

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Key information

Conditions

Pain Agnosia Anxiety Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Center

Pasadena, California, 91105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DEX-IN

Drug

IN Dexmedetomidine + IV placebo

Fentanyl

Drug

IN Placebo + IV Fentanyl

Placebo

Drug

IN Placebo + IV Placebo

Primary outcomes

  1. Evaluation of Pain Intensity - Mean Pain Score During Procedure

    Time frame: Up to 4 Hours

    Evaluation of subject reported pain intensity scores according to the 11-point Numeric Pain Rating Scale (NPRS; 0-10)

Sponsors and collaborators

Lead sponsor

Baudax Bio

Industry

Registry information

Official study title

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Evaluation of the Efficacy and Safety of DEX-IN Following Painful Outpatient Procedures

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 20, 2017
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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