VPD-737 for Treatment of Chronic Pruritus
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
1 other identifier
interventional
257
1 country
25
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2013
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2013
CompletedFirst Posted
Study publicly available on registry
September 26, 2013
CompletedStudy Start
First participant enrolled
October 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2014
CompletedMay 13, 2022
May 1, 2022
1.1 years
July 19, 2013
May 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Analog Scale
6 weeks
Secondary Outcomes (1)
Verbal Response Scale
6 weeks
Study Arms (4)
0.25 mg VPD-737
EXPERIMENTAL0.25 mg of VPD-737 daily by mouth for 42 days
1 mg VPD-737
EXPERIMENTAL1 mg VPD-737 taken daily by mouth for 42 days
5 mg VPD-737
EXPERIMENTAL5 mg tablets of VPD-737 to be taken daily by mouth for 42 days
Placebo
PLACEBO COMPARATORplacebo tablets to be taken daily by mouth for 42 days
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of chronic pruritus and unresponsive to current therapies
You may not qualify if:
- Have chronic liver or renal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
Torrance Clinical Research Institute Inc.
Lomita, California, 90717, United States
Stanford University, Medical Dermatology
Redwood City, California, 94063, United States
UCSD Dermatology
San Diego, California, United States
The Center for Clinical and Cosmetic Research
Aventura, Florida, 33180, United States
Dermatology of Boca
Boca Raton, Florida, 33431, United States
Skin Care Research
Boca Raton, Florida, 33486, United States
Olympian Clinical Research
Tampa, Florida, 33609, United States
Advanced Medical Research, Inc.
Atlanta, Georgia, 30342, United States
Shideler Clinical Research Center
Carmel, Indiana, 46032, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
Grekin Skin Institue
Warren, Michigan, 48088, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Quality Clinical Research Inc.
Omaha, Nebraska, 68114, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
The Dermatology Group, P.C.
Verona, New Jersey, 07044, United States
Skin Search of Rochester, Inc.
Rochester, New York, 14623, United States
Dermatology Consulting Services
High Point, North Carolina, 27262, United States
Baker Allergy, Asthma and Dermatology Research Center, LLC
Lake Oswego, Oregon, 97035, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Suzanne Bruce and Associates, P.A.
Houston, Texas, 77056, United States
Pfugerville Dermatology
Pflugerville, Texas, 78660, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229, United States
WestEnd Dermatology Associates
Richmond, Virginia, 23233, United States
Marycliff Allergy Specialist
Spokane, Washington, 99204, United States
Related Publications (1)
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.
PMID: 29462657DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Edward F Schnipper, MD
Acting Chief Medical Officer, Tigercat Pharma, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2013
First Posted
September 26, 2013
Study Start
October 15, 2013
Primary Completion
December 2, 2014
Study Completion
December 2, 2014
Last Updated
May 13, 2022
Record last verified: 2022-05