VPD-737 for Treatment of Chronic Pruritus

Chronic Pruritus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01951274
• Other study ID #: TCP 101
• Status: Completed
• Phase: Phase 2
• Start date: October 15, 2013
• Est. completion date: December 2, 2014

Study information

• Verified date: May 2022
• Source: Vyne Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: December 2, 2014
• Est. primary completion date: December 2, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of chronic pruritus and unresponsive to current therapies

Exclusion Criteria:

• Have chronic liver or renal disease

Related Conditions & MeSH terms

• Chronic Pruritus
• Pruritus

Intervention

Drug:
• VPD-737
NK1 Receptor Antagonist
• Placebo

Locations

Country	Name	City	State
United States	Advanced Medical Research, Inc.	Atlanta	Georgia
United States	The Center for Clinical and Cosmetic Research	Aventura	Florida
United States	Comprehensive Clinical Research	Berlin	New Jersey
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	Center for Dermatology Clinical Research, Inc.	Fremont	California
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Suzanne Bruce and Associates, P.A.	Houston	Texas
United States	Baker Allergy, Asthma and Dermatology Research Center, LLC	Lake Oswego	Oregon
United States	Torrance Clinical Research Institute Inc.	Lomita	California
United States	Quality Clinical Research Inc.	Omaha	Nebraska
United States	Pfugerville Dermatology	Pflugerville	Texas
United States	Temple University	Philadelphia	Pennsylvania
United States	The Indiana Clinical Trials Center, PC	Plainfield	Indiana
United States	Stanford University, Medical Dermatology	Redwood City	California
United States	WestEnd Dermatology Associates	Richmond	Virginia
United States	Skin Search of Rochester, Inc.	Rochester	New York
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	UCSD Dermatology	San Diego	California
United States	Marycliff Allergy Specialist	Spokane	Washington
United States	Olympian Clinical Research	Tampa	Florida
United States	The Dermatology Group, P.C.	Verona	New Jersey
United States	Grekin Skin Institue	Warren	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Vyne Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale		6 weeks
Secondary	Verbal Response Scale		6 weeks