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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02004041
Other study ID # VP-VLY-686-2101
Secondary ID 2013-002931-25
Status Completed
Phase Phase 2
First received
Last updated
Start date December 10, 2013
Est. completion date February 19, 2015

Study information

Verified date May 2024
Source Vanda Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is randomized, double-blind, placebo-controlled study to test whether VLY-686 can reduce chronic pruritus in subjects with treatment-resistant pruritus associated with atopic dermatitis in comparison with placebo.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date February 19, 2015
Est. primary completion date February 19, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Men and women ages 18 - 65 years, inclusive; suffering from atopic dermatitis with a SCORAD index at inclusion =80; with atopic lesions on arms, legs, trunk and neck; - Chronic pruritus with pruritus being actively present for at least 6 weeks prior to screening; - Males, non-fecund females, or females of child-bearing potential using 2 independent highly effective barrier methods of birth control when used correctly for a period of 35 days before the first dosing, during the study and for one month after the last dose and must have a negative pregnancy test at the screening and baseline visits. Exclusion Criteria: - Chronic pruritus due to conditions other than atopic dermatitis (AD) including the following conditions: Prurigo nodularis, Lichen simplex chronicus, Bullous pemphigoid; - Acute superinfection of AD.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
VLY-686

Placebo


Locations

Country Name City State
Germany Vanda Investigational Site Dusseldorf
Germany Vanda Investigational Site Hamburg
Germany Vanda Investigational Site Jena
Germany Vanda Investigational Site Kiel
Germany Vanda Investigational Site Munster

Sponsors (1)

Lead Sponsor Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity. Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left end point was marked "no itch" (0 mm) and in the right end point was marked "worst imaginable itch" (100 mm). 28 days