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NCT02651714 Clinical Trial

Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02651714
Other study ID # VP-VLY-686-2102
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 19, 2016
Est. completion date August 4, 2017

Study information
Verified date May 2024
Source Vanda Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Other known NCT identifiers
  • NCT02672410

Recruitment information / eligibility
Status Completed
Enrollment 168
Est. completion date August 4, 2017
Est. primary completion date August 4, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tradipitant

• Placebo

Locations
Country Name City State
United States Vanda Investigational Site Charleston South Carolina
United States Vanda Investigational Site Columbus Georgia
United States Vanda Investigational Site Crowley Louisiana
United States Vanda Investigational Site Encinitas California
United States Vanda Investigational Site Encino California
United States Vanda Investigational Site High Point North Carolina
United States Vanda Investigational Site Houston Texas
United States Vanda Investigational Site Johnston Rhode Island
United States Vanda Investigational Site Las Vegas Nevada
United States Vanda Investigational Site Lomita California
United States Vanda Investigational Site Miami Florida
United States Vanda Investigational Site Miami Florida
United States Vanda Investigational Site New York New York
United States Vanda Investigational Site New York New York
United States Vanda Investigational Site Ormond Beach Florida
United States Vanda Investigational Site Pflugerville Texas
United States Vanda Investigational Site Philadelphia Pennsylvania
United States Vanda Investigational Site Plainfield Indiana
United States Vanda Investigational Site Portland Oregon
United States Vanda Investigational Site Saint Louis Missouri
United States Vanda Investigational Site San Antonio Texas
United States Vanda Investigational Site San Diego California
United States Vanda Investigational Site San Diego California
United States Vanda Investigational Site Seattle Washington
United States Vanda Investigational Site Spokane Washington
United States Vanda Investigational Site West Jordan Utah
United States Vanda Investigational Site Wilmington North Carolina
United States Vanda Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left endpoint was marked "no itch" (0 mm) and in the right endpoint was marked "worst imaginable itch" (100 mm). 56 days
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