Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05978063
Status:
TERMINATED
Last Update Posted:
2024-06-21
First Post:
2023-07-25
Brief Title:
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica
Sponsor:
Cara Therapeutics Inc
Organization:
Cara Therapeutics Inc
Study Overview
Official Title:
A 2-part Multicenter Randomized Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate-to-Severe Pruritus in Adult Subjects With Notalgia Paresthetica
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 subjects with NP
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 study comprises a 28-day Screening Period a 7-day Run-in Period an 8-week Double-blind Treatment Period a 2-week Treatment Discontinuation Period and a Safety Follow-up Visit 14 days after the last dose of study treatment
Part B of this study will evaluate the efficacy safety and tolerability of oral difelikefalin The dose of oral difelikefalin to be assessed in Part B will depend on the results of Part A Part B of this study comprises a 28-day Screening Period a 7-day Run-in Period an 8-week Double-blind Treatment Period up to a 52-week OLE Period and a Safety Follow-up Visit
Subjects who participated in Part A of the study may not participate in Part B
All subjects will sign an informed consent form ICF and undergo screening for study eligibility
Part B of this study will evaluate the efficacy safety and tolerability of oral difelikefalin The dose of oral difelikefalin to be assessed in Part B will depend on the results of Part A Part B of this study comprises a 28-day Screening Period a 7-day Run-in Period an 8-week Double-blind Treatment Period up to a 52-week OLE Period and a Safety Follow-up Visit
Subjects who participated in Part A of the study may not participate in Part B
All subjects will sign an informed consent form ICF and undergo screening for study eligibility
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None