Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

NCT ID: NCT02651714

Last Updated: 2024-06-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-19

Study Completion Date

2017-08-04

Brief Summary

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This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with treatment-resistant pruritus diagnosed with atopic dermatitis.

Detailed Description

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Conditions

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Atopic Dermatitis

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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Tradipitant

Oral

Group Type EXPERIMENTAL

Tradipitant

Intervention Type DRUG

Placebo

Oral

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Tradipitant

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and non-pregnant, non-lactating female subjects aged 18 - 65 years (inclusive)
* Diagnosed with atopic dermatitis
* Suffering from chronic pruritus with pruritus being actively present

Exclusion Criteria

* Chronic pruritus due to condition other than atopic dermatitis (AD)
* Participation in a previous tradipitant (LY686017 or VLY-686) trial
* Anyone affiliated with the site or sponsor and/or anyone who may consent under duress
* Any other sound medical reason as determined by the Investigator including any condition which may lead to an unfavorable risk-benefit of study participation, may interfere with study compliance or may confound study results
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanda Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vanda Investigational Site

Encinitas, California, United States

Site Status

Vanda Investigational Site

Encino, California, United States

Site Status

Vanda Investigational Site

Lomita, California, United States

Site Status

Vanda Investigational Site

San Diego, California, United States

Site Status

Vanda Investigational Site

San Diego, California, United States

Site Status

Vanda Investigational Site

Miami, Florida, United States

Site Status

Vanda Investigational Site

Miami, Florida, United States

Site Status

Vanda Investigational Site

Ormond Beach, Florida, United States

Site Status

Vanda Investigational Site

Columbus, Georgia, United States

Site Status

Vanda Investigational Site

Plainfield, Indiana, United States

Site Status

Vanda Investigational Site

Crowley, Louisiana, United States

Site Status

Vanda Investigational Site

St Louis, Missouri, United States

Site Status

Vanda Investigational Site

Las Vegas, Nevada, United States

Site Status

Vanda Investigational Site

New York, New York, United States

Site Status

Vanda Investigational Site

New York, New York, United States

Site Status

Vanda Investigational Site

High Point, North Carolina, United States

Site Status

Vanda Investigational Site

Wilmington, North Carolina, United States

Site Status

Vanda Investigational Site

Winston-Salem, North Carolina, United States

Site Status

Vanda Investigational Site

Portland, Oregon, United States

Site Status

Vanda Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Vanda Investigational Site

Johnston, Rhode Island, United States

Site Status

Vanda Investigational Site

Charleston, South Carolina, United States

Site Status

Vanda Investigational Site

Houston, Texas, United States

Site Status

Vanda Investigational Site

Pflugerville, Texas, United States

Site Status

Vanda Investigational Site

San Antonio, Texas, United States

Site Status

Vanda Investigational Site

West Jordan, Utah, United States

Site Status

Vanda Investigational Site

Seattle, Washington, United States

Site Status

Vanda Investigational Site

Spokane, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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VP-VLY-686-2102

Identifier Type: -

Identifier Source: org_study_id

NCT02672410

Identifier Type: -

Identifier Source: nct_alias

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