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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 January 6, 2016
Last updated October 31, 2017
Start date January 2016
Est. completion date September 2017

Study information
Verified date October 2017
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 September 2017
Est. primary completion date September 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
n/a

Sponsors (1)
Lead Sponsor Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of tradipitant relative to placebo in reducing chronic pruritus as measured by the Visual Analogue Scale (VAS). Starting at week 2.
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