VPD-737 for Treatment of Chronic Pruritus

NCT ID: NCT01951274

Last Updated: 2022-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-15

Study Completion Date

2014-12-02

Brief Summary

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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

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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

Conditions

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Chronic Pruritus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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0.25 mg VPD-737

0.25 mg of VPD-737 daily by mouth for 42 days

Group Type EXPERIMENTAL

VPD-737

Intervention Type DRUG

NK1 Receptor Antagonist

1 mg VPD-737

1 mg VPD-737 taken daily by mouth for 42 days

Group Type EXPERIMENTAL

VPD-737

Intervention Type DRUG

NK1 Receptor Antagonist

5 mg VPD-737

5 mg tablets of VPD-737 to be taken daily by mouth for 42 days

Group Type EXPERIMENTAL

VPD-737

Intervention Type DRUG

NK1 Receptor Antagonist

Placebo

placebo tablets to be taken daily by mouth for 42 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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VPD-737

NK1 Receptor Antagonist

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Serlopitant

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of chronic pruritus and unresponsive to current therapies

Exclusion Criteria

* Have chronic liver or renal disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vyne Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward F Schnipper, MD

Role: STUDY_DIRECTOR

Acting Chief Medical Officer, Tigercat Pharma, Inc.

Locations

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Center for Dermatology Clinical Research, Inc.

Fremont, California, United States

Site Status

Torrance Clinical Research Institute Inc.

Lomita, California, United States

Site Status

Stanford University, Medical Dermatology

Redwood City, California, United States

Site Status

UCSD Dermatology

San Diego, California, United States

Site Status

The Center for Clinical and Cosmetic Research

Aventura, Florida, United States

Site Status

Dermatology of Boca

Boca Raton, Florida, United States

Site Status

Skin Care Research

Boca Raton, Florida, United States

Site Status

Olympian Clinical Research

Tampa, Florida, United States

Site Status

Advanced Medical Research, Inc.

Atlanta, Georgia, United States

Site Status

Shideler Clinical Research Center

Carmel, Indiana, United States

Site Status

The Indiana Clinical Trials Center, PC

Plainfield, Indiana, United States

Site Status

Grekin Skin Institue

Warren, Michigan, United States

Site Status

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Site Status

Quality Clinical Research Inc.

Omaha, Nebraska, United States

Site Status

Comprehensive Clinical Research

Berlin, New Jersey, United States

Site Status

The Dermatology Group, P.C.

Verona, New Jersey, United States

Site Status

Skin Search of Rochester, Inc.

Rochester, New York, United States

Site Status

Dermatology Consulting Services

High Point, North Carolina, United States

Site Status

Baker Allergy, Asthma and Dermatology Research Center, LLC

Lake Oswego, Oregon, United States

Site Status

Temple University

Philadelphia, Pennsylvania, United States

Site Status

Suzanne Bruce and Associates, P.A.

Houston, Texas, United States

Site Status

Pfugerville Dermatology

Pflugerville, Texas, United States

Site Status

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Site Status

WestEnd Dermatology Associates

Richmond, Virginia, United States

Site Status

Marycliff Allergy Specialist

Spokane, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29462657 (View on PubMed)

Other Identifiers

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TCP 101

Identifier Type: -

Identifier Source: org_study_id

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