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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.
 
ClinicalTrials.gov Identifier: NCT02975271
Recruitment Status : Terminated (Business Reasons)
First Posted : November 29, 2016
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Menlo Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE November 22, 2016
First Posted Date  ICMJE November 29, 2016
Last Update Posted Date March 1, 2018
Actual Study Start Date  ICMJE November 2016
Actual Primary Completion Date January 17, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
Change in Itch Intensity - Numeric Rating Scale [ Time Frame: Week 6 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2016)
Itch Intensity - Numeric Rating Scale [ Time Frame: Week 6 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
Itch Intensity Responder Rate - Numeric Rating Scale [ Time Frame: Week 6 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2016)
Change in Itch Intensity - Numeric Rating Scale [ Time Frame: Week 6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus Following Burn Injury
Brief Summary Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pruritus
  • Burns
Intervention  ICMJE
  • Drug: Serlopitant
  • Drug: Placebo
    Matching placebo
Study Arms  ICMJE
  • Experimental: Serlopitant
    Dose of experimental drug Serlopitant
    Intervention: Drug: Serlopitant
  • Placebo Comparator: Placebo
    Matching dose of Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 7, 2017)
1
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2016)
150
Actual Study Completion Date  ICMJE January 18, 2017
Actual Primary Completion Date January 17, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02975271
Other Study ID Numbers  ICMJE MTI-104
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Menlo Therapeutics Inc.
Study Sponsor  ICMJE Menlo Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Menlo Therapeutics Inc.
Verification Date February 2018

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