VPD-737 for Treatment of Chronic Pruritus

Phase 2

Completed

• Conditions: Chronic Pruritus
• Interventions: Drug: Placebo; Drug: VPD-737

• 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

Study Timeline

• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-09-25
• Study First Posted: 2013-09-26
• Study Start: 2013-10-15
• Primary Completion: 2014-12-02
• Study Completion: 2014-12-02
• Disposition First Submitted: 2020-08-14
• Disposition First Submitted QC: 2020-08-20
• Disposition First Posted: 2020-08-26
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-10
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

Inclusion Criteria

• Clinical diagnosis of chronic pruritus and unresponsive to current therapies

Exclusion Criteria

• Have chronic liver or renal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo tablets to be 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
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

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)

Center for Dermatology Clinical Research, Inc.; 🇺🇸 Fremont, California, United States

Torrance Clinical Research Institute Inc.; 🇺🇸 Lomita, California, United States

Stanford University, Medical Dermatology; 🇺🇸 Redwood City, California, United States

UCSD Dermatology; 🇺🇸 San Diego, California, United States

The Center for Clinical and Cosmetic Research; 🇺🇸 Aventura, Florida, United States

Dermatology of Boca; 🇺🇸 Boca Raton, Florida, United States

Skin Care Research; 🇺🇸 Boca Raton, Florida, United States

Olympian Clinical Research; 🇺🇸 Tampa, Florida, United States

Advanced Medical Research, Inc.; 🇺🇸 Atlanta, Georgia, United States

Shideler Clinical Research Center; 🇺🇸 Carmel, Indiana, United States

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