drugset / Trial / NCT05978063
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica
RandomizedParallel-groupDouble-blindTreatment
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 subjects with NP.
Timeline
- Start
- 2023-08-01
- Primary completion
- 2024-04-22
- Completion
- 2024-05-07
Outcome
Outcome not reported
Stopped: “In Part A of CR845-310601, oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo. The drug was generally well tolerated with a safety profile similar to prior trials.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Difelikefalin | Protein / enzyme biologic | 0.25 mg | Oral |
| Comparator | Difelikefalin | Protein / enzyme biologic | 1 mg | Oral |
| Comparator | Difelikefalin | Protein / enzyme biologic | 2 mg | Oral |
Indications
No indication recorded.