VPD-737 for Treatment of Chronic Pruritus
- Conditions
- Chronic Pruritus
- Interventions
- Drug: VPD-737Drug: Placebo
- Registration Number
- NCT01951274
- Lead Sponsor
- Vyne Therapeutics Inc.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 257
- Clinical diagnosis of chronic pruritus and unresponsive to current therapies
- Have chronic liver or renal disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.25 mg VPD-737 VPD-737 0.25 mg of VPD-737 daily by mouth for 42 days 1 mg VPD-737 VPD-737 1 mg VPD-737 taken daily by mouth for 42 days 5 mg VPD-737 VPD-737 5 mg tablets of VPD-737 to be taken daily by mouth for 42 days Placebo Placebo placebo tablets to be taken daily by mouth for 42 days
- Primary Outcome Measures
Name Time Method Visual Analog Scale 6 weeks
- Secondary Outcome Measures
Name Time Method Verbal Response Scale 6 weeks
Trial Locations
- Locations (25)
Stanford University, Medical Dermatology
🇺🇸Redwood City, California, United States
Dermatology of Boca
🇺🇸Boca Raton, Florida, United States
Skin Care Research
🇺🇸Boca Raton, Florida, United States
Shideler Clinical Research Center
🇺🇸Carmel, Indiana, United States
Grekin Skin Institue
🇺🇸Warren, Michigan, United States
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
Suzanne Bruce and Associates, P.A.
🇺🇸Houston, Texas, United States
Quality Clinical Research Inc.
🇺🇸Omaha, Nebraska, United States
The Center for Clinical and Cosmetic Research
🇺🇸Aventura, Florida, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Dermatology Clinical Research Center of San Antonio
🇺🇸San Antonio, Texas, United States
Dermatology Consulting Services
🇺🇸High Point, North Carolina, United States
Advanced Medical Research, Inc.
🇺🇸Atlanta, Georgia, United States
The Indiana Clinical Trials Center, PC
🇺🇸Plainfield, Indiana, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
Baker Allergy, Asthma and Dermatology Research Center, LLC
🇺🇸Lake Oswego, Oregon, United States
Marycliff Allergy Specialist
🇺🇸Spokane, Washington, United States
Pfugerville Dermatology
🇺🇸Pflugerville, Texas, United States
Center for Dermatology Clinical Research, Inc.
🇺🇸Fremont, California, United States
Torrance Clinical Research Institute Inc.
🇺🇸Lomita, California, United States
UCSD Dermatology
🇺🇸San Diego, California, United States
Skin Search of Rochester, Inc.
🇺🇸Rochester, New York, United States
The Dermatology Group, P.C.
🇺🇸Verona, New Jersey, United States
Olympian Clinical Research
🇺🇸Tampa, Florida, United States
WestEnd Dermatology Associates
🇺🇸Richmond, Virginia, United States