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Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT02651714
Recruitment Status : Completed
First Posted : January 11, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Chronic Pruritus Drug: Tradipitant Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching

Arm Intervention/treatment
Placebo Comparator: Placebo
Oral
Drug: Placebo
Experimental: Tradipitant
Oral
Drug: Tradipitant



Primary Outcome Measures :
  1. Efficacy of tradipitant relative to placebo in reducing chronic pruritus as measured by the Visual Analogue Scale (VAS). [ Time Frame: Starting at week 2. ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651714


Locations
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United States, Florida
Miami, Florida, United States
United States, New York
New York, New York, United States
United States, North Carolina
High Point, North Carolina, United States
Wilmington, North Carolina, United States
United States, Texas
Pflugerville, Texas, United States
Sponsors and Collaborators
Vanda Pharmaceuticals

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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02651714     History of Changes
Obsolete Identifiers: NCT02672410
Other Study ID Numbers: VP-VLY-686-2102
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Pruritus
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Manifestations
Signs and Symptoms