VPD-737 for Treatment of Chronic Pruritus

This study has been completed.
Information provided by (Responsible Party):
Tigercat Pharma, Inc.
ClinicalTrials.gov Identifier:
First received: July 19, 2013
Last updated: May 20, 2015
Last verified: June 2013
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

Condition Intervention Phase
Chronic Pruritus
Drug: VPD-737
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Tigercat Pharma, Inc.:

Primary Outcome Measures:
  • Visual Analog Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Verbal Response Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 257
Study Start Date: October 2013
Study Completion Date: April 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.25 mg VPD-737
0.25 mg of VPD-737 daily by mouth for 42 days
Drug: VPD-737
NK1 Receptor Antagonist
Other Name: Serlopitant
Experimental: 1 mg VPD-737
1 mg VPD-737 taken daily by mouth for 42 days
Drug: VPD-737
NK1 Receptor Antagonist
Other Name: Serlopitant
Experimental: 5 mg VPD-737
5 mg tablets of VPD-737 to be taken daily by mouth for 42 days
Drug: VPD-737
NK1 Receptor Antagonist
Other Name: Serlopitant
Placebo Comparator: Placebo
placebo tablets to be taken daily by mouth for 42 days
Drug: Placebo

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of chronic pruritus and unresponsive to current therapies

Exclusion Criteria:

  • Have chronic liver or renal disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01951274

  Show 25 Study Locations
Sponsors and Collaborators
Tigercat Pharma, Inc.
Study Director: Edward F Schnipper, MD Acting Chief Medical Officer, Tigercat Pharma, Inc.
  More Information

Responsible Party: Tigercat Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01951274     History of Changes
Other Study ID Numbers: TCP 101 
Study First Received: July 19, 2013
Last Updated: May 20, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Signs and Symptoms
Skin Diseases
Skin Manifestations

ClinicalTrials.gov processed this record on May 24, 2016