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Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury (AUBURN)

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. Read our disclaimer for details. Identifier: NCT02975271
Recruitment Status : Terminated (Business Reasons)
First Posted : November 29, 2016
Last Update Posted : May 20, 2021
Information provided by (Responsible Party):
Vyne Therapeutics Inc.

Brief Summary:
Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury

Condition or disease Intervention/treatment Phase
Pruritus Burns Drug: Serlopitant Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus Following Burn Injury
Actual Study Start Date : November 2016
Actual Primary Completion Date : January 17, 2017
Actual Study Completion Date : January 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Itching

Arm Intervention/treatment
Experimental: Serlopitant
Dose of experimental drug Serlopitant
Drug: Serlopitant
Placebo Comparator: Placebo
Matching dose of Placebo
Drug: Placebo
Matching placebo

Primary Outcome Measures :
  1. Change in Itch Intensity - Numeric Rating Scale [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. Itch Intensity Responder Rate - Numeric Rating Scale [ Time Frame: Week 6 ]

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.

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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

Key Inclusion Criteria:

  • Male or female, age 18-65 years at consent.
  • History of serious burn injury
  • Pruritus (itchiness) prior to the initial screening visit and during the screening period
  • Judged to be in good health in the investigator's opinion.

Key Exclusion Criteria:

  • Prior treatment with study drug or similar drug
  • Pruritus (itchiness) due to another reason besides burn injury/ healing.
  • Presence of any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
  • History of hypersensitivity to study drug or any of its components.
  • Currently pregnant or male partner of pregnant female.
  • Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding.

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): NCT02975271

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United States, Arizona
Study Site 404
Phoenix, Arizona, United States
United States, District of Columbia
Study Site 402
Washington, District of Columbia, United States
United States, Florida
Study Site 412
Gainesville, Florida, United States
Study Site 403
Tampa, Florida, United States
United States, Nebraska
Study Site 409
Lincoln, Nebraska, United States
United States, North Carolina
Study Site 401
Winston-Salem, North Carolina, United States
United States, Washington
Study Site 413
Seattle, Washington, United States
Sponsors and Collaborators
Vyne Therapeutics Inc.
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Responsible Party: Vyne Therapeutics Inc. Identifier: NCT02975271    
Other Study ID Numbers: MTI-104
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: May 20, 2021
Last Verified: May 2021
Additional relevant MeSH terms:
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Wounds and Injuries
Skin Diseases
Skin Manifestations
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs