Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis
- Registration Number
- NCT02651714
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 168
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tradipitant Tradipitant Oral Placebo Placebo Oral
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Pruritus Symptoms, as Measured by the 24-hour Average Pruritus Visual Analogue Scale (VAS) Score 56 days 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vanda Investigational Site
🇺🇸Spokane, Washington, United States