Status:
TERMINATED
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica
Lead Sponsor:
Cara Therapeutics, Inc.
Conditions:
Pruritus
Notalgia Paresthetica
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a 2-part, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin for moderate-to-severe pruritus in adult s...
Detailed Description
Part A of this study will evaluate the benefit-risk of 3 doses of difelikefalin compared to placebo. The dose with the best benefit-risk profile will be further evaluated in Part B. Part A of this stu...
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 :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2024
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT05978063
Start Date
August 1 2023
End Date
May 7 2024
Last Update
June 21 2024
Active Locations (58)
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1
Cara Therapeutics Study Site
Birmingham, Alabama, United States, 35244
2
Cara Therapeutics Study Site
Phoenix, Arizona, United States, 85032
3
Cara Therapeutics Study Site
Fayetteville, Arkansas, United States, 72703
4
Cara Therapeutics Study Site
Hot Springs, Arkansas, United States, 71913