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Trial record 3 of 259505 for:    ALL

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.
  Purpose
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 Intervention Phase
Pain Drug: DEX-IN Drug: Fentanyl Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Recro Pharma, Inc.:

Primary Outcome Measures:
  • 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)


Estimated Enrollment: 45
Actual Study Start Date: November 15, 2017
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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.
  More Information

Responsible Party: Recro Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03348423     History of Changes
Other Study ID Numbers: REC-17-023
First Submitted: November 16, 2017
First Posted: November 20, 2017
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