Evaluation of DEX-IN During Outpatient Procedures

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. Identifier: NCT03348423
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : November 20, 2017
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

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
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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT03348423

Contact: Stewart McCallum, MD 484-395-2470 ext 2411
Contact: Randall Mack 484-395-2470 ext 2406

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

Responsible Party: Recro Pharma, Inc. 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

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