Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)
Lead Sponsor:
Cara Therapeutics, Inc.
Conditions:
Pruritus
Notalgia Paresthetica
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 parestheti...
Detailed 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 approximatel...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04706975
Start Date
January 11 2021
End Date
June 30 2022
Last Update
May 22 2023
Active Locations (36)
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1
Cara Therapeutics Study Site
Fort Smith, Arkansas, United States, 72916
2
Cara Therapeutics Study Site
Hot Springs, Arkansas, United States, 71913
3
Cara Therapeutics Study Site
Rogers, Arkansas, United States, 72758
4
Cara Therapeutics Study Site
Fountain Valley, California, United States, 92708