Clinical trial NCT02651714: Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: eczema
chronic pruritus
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-01-11
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score
timeFrame: 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Vanda Investigational Site
state: California
city: Encino
country: United States
facility: Vanda Investigational Site
state: California
city: Lomita
country: United States
facility: Vanda Investigational Site
state: California
city: San Diego
country: United States
facility: Vanda Investigational Site
state: California
city: San Diego
country: United States
facility: Vanda Investigational Site
state: California
city: Miami
country: United States
facility: Vanda Investigational Site
state: Florida
city: Miami
country: United States
facility: Vanda Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Vanda Investigational Site
state: Florida
city: Columbus
country: United States
facility: Vanda Investigational Site
state: Georgia
city: Plainfield
country: United States
facility: Vanda Investigational Site
state: Indiana
city: Crowley
country: United States
facility: Vanda Investigational Site
state: Louisiana
city: Saint Louis
country: United States
facility: Vanda Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Vanda Investigational Site
state: Nevada
city: New York
country: United States
facility: Vanda Investigational Site
state: New York
city: New York
country: United States
facility: Vanda Investigational Site
state: New York
city: High Point
country: United States
facility: Vanda Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Vanda Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Vanda Investigational Site
state: North Carolina
city: Portland
country: United States
facility: Vanda Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Vanda Investigational Site
state: Pennsylvania
city: Johnston
country: United States
facility: Vanda Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Vanda Investigational Site
state: South Carolina
city: Houston
country: United States
facility: Vanda Investigational Site
state: Texas
city: Pflugerville
country: United States
facility: Vanda Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Vanda Investigational Site
state: Texas
city: West Jordan
country: United States
facility: Vanda Investigational Site
state: Utah
city: Seattle
country: United States
facility: Vanda Investigational Site
state: Washington
city: Spokane
country: United States
facility: Vanda Investigational Site
state: Washington
Study officials:
References: