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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.25 mg VPD-737 | Experimental | 0.25 mg of VPD-737 daily by mouth for 42 days |
|
| 1 mg VPD-737 | Experimental | 1 mg VPD-737 taken daily by mouth for 42 days |
|
| 5 mg VPD-737 | Experimental | 5 mg tablets of VPD-737 to be taken daily by mouth for 42 days |
|
| Placebo | Placebo Comparator | placebo tablets to be taken daily by mouth for 42 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VPD-737 | Drug | NK1 Receptor Antagonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Response Scale | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward F Schnipper, MD | Acting Chief Medical Officer, Tigercat Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Dermatology Clinical Research, Inc. | Fremont | California | 94538 | United States | ||
| Torrance Clinical Research Institute Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29462657 | Derived | 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. |
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| Placebo | Drug |
|
| 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 |
| ID | Term |
|---|---|
| C551592 | serlopitant |
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