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Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis, Eczema, Chronic Pruritus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tradipitant
Placebo
Sponsored by
Vanda Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Tradipitant

Arm Description

Oral

Oral

Outcomes

Primary Outcome Measures

Efficacy of tradipitant relative to placebo in reducing chronic pruritus as measured by the Visual Analogue Scale (VAS).

Secondary Outcome Measures

Full Information

First Posted
January 6, 2016
Last Updated
October 31, 2017
Sponsor
Vanda Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02651714
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema, Chronic Pruritus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral
Arm Title
Tradipitant
Arm Type
Experimental
Arm Description
Oral
Intervention Type
Drug
Intervention Name(s)
Tradipitant
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Efficacy of tradipitant relative to placebo in reducing chronic pruritus as measured by the Visual Analogue Scale (VAS).
Time Frame
Starting at week 2.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
City
Miami
State/Province
Florida
Country
United States
City
New York
State/Province
New York
Country
United States
City
High Point
State/Province
North Carolina
Country
United States
City
Wilmington
State/Province
North Carolina
Country
United States
City
Pflugerville
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

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