Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)

  • STATUS
    Recruiting
  • End date
    Mar 15, 2022
  • participants needed
    120
  • sponsor
    Cara Therapeutics, Inc.
Updated on 16 May 2021

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with notalgia paresthetica and moderate to severe pruritus.

Description

The study will consist of a 37-day Screening period, a 7-day Run-In period, a 8-week Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow Up visit approximately 14 days after the last dose of study drug.

All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility.

Subjects will be randomized to receive either placebo or difelikefalin (CR845) tablets at a dose of 2.0 mg, orally BID. Intake of the first dose of study drug will be at Day 1.

Subjects who complete the Placebo-Controlled Treatment period of the study will transition into the Active Extension period upon completion of the Week 8 visit assessments. All subjects in the Active Extension will receive difelikefalin (CR845).

Details
Condition Pruritus, Dermatosis, Congenital Skin Diseases, Skin Conditions, Notalgia Paresthetica
Treatment Placebo, difelikefalin 2.0 mg
Clinical Study IdentifierNCT04706975
SponsorCara Therapeutics, Inc.
Last Modified on16 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

To be eligible for inclusion into the study, a patient must meet the following
criteria
Subject has clinically confirmed diagnosis of active Notalgia Paresthetica
Subject has a history of chronic pruritus due to Notalgia Paresthetica
Subject has moderate to severe pruritus
Female subject is not pregnant or nursing during any period of the study

Exclusion Criteria

A patient will be excluded from the study if any of the following criteria are
met
Subject has pruritus attributed to a cause other than Notalgia Paresthetica
Subject has any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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