Clinical trial NCT01951274: VPD-737 for Treatment of Chronic Pruritus
Official title: A Phase II Randomized, Double Blind, Parallel Group, Placebo-Controlled Dose Finding and Efficacy Study of VPD-737 in the Treatment of Subjects With Chronic Pruritus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Pruritus
Lead sponsor: Vyne Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2013-09-26
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study of a several doses of a novel treatment for chronic itch compared to placebo for patients whose condition has not responded to other treatments

Detailed description: The sensation of itch is transmitted to the brain through the nervous system Several chemicals are involved in transmitting this signal This trial of VPD 737 is intended to treat this condition by blocking one of the chemicals involved in the transmission of the itch signal This is an oral drug administered once daily It has been used in other trials and has shown to be safe at the doses used in this trial The trial will involve once daily pills for 6 weeks. Subject will be asked to fill out questionnaires both electronically and on paper during the study period Patients will also be monitored for safety and will have blood taken for testing and several points during the trial Overall participation will last about 12 weeks

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic pruritus and unresponsive to current therapies

Exclusion Criteria:

* Have chronic liver or renal disease

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 6 weeks
Secondary outcomes:
measure: Verbal Response Scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute Inc.
state: California
city: Redwood City
country: United States
facility: Stanford University, Medical Dermatology
state: California
city: San Diego
country: United States
facility: UCSD Dermatology
state: California
city: Aventura
country: United States
facility: The Center for Clinical and Cosmetic Research
state: Florida
city: Boca Raton
country: United States
facility: Dermatology of Boca
state: Florida
city: Boca Raton
country: United States
facility: Skin Care Research
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Advanced Medical Research, Inc.
state: Georgia
city: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Warren
country: United States
facility: Grekin Skin Institue
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Omaha
country: United States
facility: Quality Clinical Research Inc.
state: Nebraska
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Verona
country: United States
facility: The Dermatology Group, P.C.
state: New Jersey
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Lake Oswego
country: United States
facility: Baker Allergy, Asthma and Dermatology Research Center, LLC
state: Oregon
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Houston
country: United States
facility: Suzanne Bruce and Associates, P.A.
state: Texas
city: Pflugerville
country: United States
facility: Pfugerville Dermatology
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Richmond
country: United States
facility: WestEnd Dermatology Associates
state: Virginia
city: Spokane
country: United States
facility: Marycliff Allergy Specialist
state: Washington
Study officials:
affiliation: Acting Chief Medical Officer, Tigercat Pharma, Inc.
name: Edward F Schnipper, MD
role: STUDY_DIRECTOR
References:
citation: Yosipovitch G, Stander S, Kerby MB, Larrick JW, Perlman AJ, Schnipper EF, Zhang X, Tang JY, Luger T, Steinhoff M. Serlopitant for the treatment of chronic pruritus: Results of a randomized, multicenter, placebo-controlled phase 2 clinical trial. J Am Acad Dermatol. 2018 May;78(5):882-891.e10. doi: 10.1016/j.jaad.2018.02.030. Epub 2018 Feb 17.