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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT04706975 (opens ClinicalTrials.gov in a new tab)Other idCR845-210601
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
126 participants (actual)
Sponsor
Cara Therapeutics, Inc. · Industry
Design
Randomized · Double masking
Countries
2 countries

United States, Canada

Start
11 Jan 2021
Primary completion
18 May 2022
Completion
30 Jun 2022
First posted
13 Jan 2021
Last update posted
22 May 2023
Conditions
Pruritus · Notalgia Paresthetica

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 2

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

    NCT04706975

    11 Jan 2021 to 30 Jun 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • difelikefalin 2.0 mgDrug
  • PlaceboDrug

Arms2

  • Active comparator

    Difelikefalin 2.0 mg

    Oral difelikefalin 2.0 mg tablet administered twice daily

  • Placebo comparator

    Placebo

    Oral placebo tablet administered twice daily

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change from baseline in the weekly mean of the daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 8.

    Time frame · Baseline, Week 8

Secondary outcomes(2)

  1. Improvement in itch-related quality of life as assessed by the change from baseline to Week 8 in total Skindex-10 Scale score

    Time frame · Baseline, Week 8

  2. Change from baseline in itch-related Sleep Disturbance Subscale measured by the Itch Medical Outcomes Study (MOS) at Week 8

    Time frame · Baseline, Week 8

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

6 results

Phase 2 Trial of Difelikefalin in Notalgia Paresthetica.

Kim et al. 2023The New England journal of medicinecited by 25

PMID 36780675DOI 10.1056/nejmoa2210699PUB-36780675

Full text at the publisher6 results
Publisher pageSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Key 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. Key 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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