Moderate-to-Severe pruritus in adult subjects with notalgia paresthetica
Conditions
Brief summary
The percentage of patients achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour Itch scores assessed on Day 2, at Week 1, 2, 4 and 8., The percentage of patients who are free or almost free of itch by achieving a weekly mean of the daily 24-hour Itch score of 0 to 1, inclusive at Week 8 (complete responder)., Mean change from baseline in the burning sensation scale at Week 8., Mean change from baseline in the skin tingling scale at Week 8., The percentage of patients with hyperpigmentation assessed as clear (0) or almost clear (1) at Week 8.
Detailed description
Number of adverse events that started after the end of treatment period based on daily assessment during the 2-week treatment discontinuation period., Safety evaluations, including number of adverse events during the study.
Interventions
DRUGDifelikefalin
DRUGPlacebo
Sponsors
Cara Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients achieving ≥4-point improvement from baseline in the weekly mean of the daily 24-hour Itch scores assessed on Day 2, at Week 1, 2, 4 and 8., The percentage of patients who are free or almost free of itch by achieving a weekly mean of the daily 24-hour Itch score of 0 to 1, inclusive at Week 8 (complete responder)., Mean change from baseline in the burning sensation scale at Week 8., Mean change from baseline in the skin tingling scale at Week 8., The percentage of patients with hyperpigmentation assessed as clear (0) or almost clear (1) at Week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse events that started after the end of treatment period based on daily assessment during the 2-week treatment discontinuation period., Safety evaluations, including number of adverse events during the study. | — |
Countries
Germany, Poland, Spain
Outcome results
None listed