Clinical Trial Details

Overview

Research Study Summary

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus Following Burn Injury

Purpose

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

To Learn more

CW ID: 224046
Date Last Changed: April 6, 2017

Clinical Trial Snapshot

Phase
2
Gender
Both Male and Female
Age
18 to 65 Years
Overall Status
Recruiting
Lead Sponsor
Menlo Therapeutics, Inc.
Facility Type
Out-Patient

Eligibility

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.

Contact

Rachel Karlnoski
University of South Florida - Tampa General Hospital
1 Tampa General Circle
Tampa, FL 33606
Phone: (813) 844-4133

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