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VPD-737 for Treatment of Chronic Pruritus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01951274
First Posted: September 26, 2013
Last Update Posted: May 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Menlo Therapeutics Inc.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Menlo Therapeutics Inc.:

Primary Outcome Measures:
  • Visual Analog Scale [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Verbal Response Scale [ Time Frame: 6 weeks ]

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951274


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

Responsible Party: Menlo Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01951274     History of Changes
Other Study ID Numbers: TCP 101
First Submitted: July 19, 2013
First Posted: September 26, 2013
Last Update Posted: May 21, 2015
Last Verified: June 2013

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