VPD-737 for Treatment of Chronic Pruritus

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Tigercat Pharma, Inc.
Sponsor:
Information provided by (Responsible Party):
Tigercat Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01951274
First received: July 19, 2013
Last updated: June 25, 2014
Last verified: June 2013
  Purpose

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 ]

Estimated Enrollment: 260
Study Start Date: October 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 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

  Eligibility

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

Inclusion Criteria:

  • Clinical diagnosis of chronic pruritus and unresponsive to current therapies

Exclusion Criteria:

  • Have chronic liver or renal disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01951274

Contacts
Contact: Michael Dunn 201-587-0500 ext 3391

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

No publications provided

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: June 25, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 14, 2014