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Evaluation of DEX-IN During Outpatient Procedures

This study is currently recruiting participants.
Verified November 2017 by Recro Pharma, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03348423
First Posted: November 20, 2017
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Recro Pharma, Inc.
November 16, 2017
November 20, 2017
November 20, 2017
November 15, 2017
April 2018   (Final data collection date for primary outcome measure)
Evaluation of Pain Intensity [ 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)
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blind, double-dummy
Primary Purpose: Treatment
Pain
  • Drug: DEX-IN
    IN Dexmedetomidine + IV placebo
  • Drug: Fentanyl
    IN Placebo + IV Fentanyl
  • Drug: Placebo
    IN Placebo + IV Placebo
  • Experimental: DEX-IN 50 µg
    Dexmedetomidine Intranasal Spray
    Intervention: Drug: DEX-IN
  • Active Comparator: Fentanyl 50 µg
    Intravenous Fentanyl
    Intervention: Drug: Fentanyl
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
April 2018
April 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact: Stewart McCallum, MD 484-395-2470 ext 2411 smccallum@recropharma.com
Contact: Randall Mack 484-395-2470 ext 2406 rmack@recropharma.com
United States
 
 
NCT03348423
REC-17-023
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Recro Pharma, Inc.
Recro Pharma, Inc.
Not Provided
Not Provided
Recro Pharma, Inc.
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP