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Evaluation of DEX-IN During Outpatient Procedures

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ClinicalTrials.gov Identifier: NCT03348423
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Recro Pharma, Inc.

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.

Condition or disease Intervention/treatment Phase
Pain Drug: DEX-IN Drug: Fentanyl Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind, double-dummy
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: DEX-IN 50 µg
Dexmedetomidine Intranasal Spray
Drug: DEX-IN
IN Dexmedetomidine + IV placebo
Active Comparator: Fentanyl 50 µg
Intravenous Fentanyl
Drug: Fentanyl
IN Placebo + IV Fentanyl
Placebo Comparator: Placebo
Placebo
Drug: Placebo
IN Placebo + IV Placebo



Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348423


Contacts
Contact: Stewart McCallum, MD 484-395-2470 ext 2411 smccallum@recropharma.com
Contact: Randall Mack 484-395-2470 ext 2406 rmack@recropharma.com

Locations
United States, California
Research Center Recruiting
Pasadena, California, United States, 91105
Sponsors and Collaborators
Recro Pharma, Inc.

Responsible Party: Recro Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03348423     History of Changes
Other Study ID Numbers: REC-17-023
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Recro Pharma, Inc.:
Peri-procedural pain
Pain
Anxiety
Analgesia
Anxiolysis

Additional relevant MeSH terms:
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics