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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-01-17

Brief Summary

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

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Detailed Description

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Conditions

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Pruritus Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Serlopitant

Dose of experimental drug Serlopitant

Group Type EXPERIMENTAL

Serlopitant

Intervention Type DRUG

Placebo

Matching dose of Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo

Interventions

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Serlopitant

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No