Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica
Pruritus, Notalgia Paresthetica
About this trial
This is an interventional treatment trial for Pruritus focused on measuring Notalgia Paresthetica, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus, NP, Neuropathic itch
Eligibility Criteria
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.
Sites / Locations
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Difelikefalin 2.0 mg tablets
Difelikefalin 1.0 mg tablets
Difelikefalin 0.25 mg tablets
Placebo tablets
Oral difelikefalin 2.0 mg tablet administered twice daily
Oral difelikefalin 1.0 mg tablet administered twice daily
Oral difelikefalin 0.25 mg tablet administered twice daily
Oral placebo tablet administered twice daily