Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04706975
Status:
COMPLETED
Last Update Posted:
2023-05-22
First Post:
2021-01-11
Brief Title:
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin CR845 for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica KOMFORT
Sponsor:
Cara Therapeutics Inc
Organization:
Cara Therapeutics Inc
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Proof-of-concept Study to Evaluate the Efficacy and Safety of Oral Difelikefalin CR845 for Moderate to Severe Pruritus in Adult Subjects With Notalgia Paresthetica
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter randomized double-blind placebo-controlled study to evaluate the efficacy and safety of twice-daily BID oral difelikefalin CR845 in adult subjects with notalgia paresthetica and moderate to severe pruritus
Detailed Description:
The study will consist of a 37-day Screening period a 7-day Run-In period a 8-week Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow Up visit approximately 14 days after the last dose of study drug
All subjects will sign an informed consent form ICF and undergo screening for study eligibility
Subjects will be randomized to receive either placebo or difelikefalin CR845 tablets at a dose of 20 mg orally BID Intake of the first dose of study drug will be at Day 1
Subjects who complete the Placebo-Controlled Treatment period of the study will transition into the Active Extension period upon completion of the Week 8 visit assessments All subjects in the Active Extension will receive difelikefalin CR845
All subjects will sign an informed consent form ICF and undergo screening for study eligibility
Subjects will be randomized to receive either placebo or difelikefalin CR845 tablets at a dose of 20 mg orally BID Intake of the first dose of study drug will be at Day 1
Subjects who complete the Placebo-Controlled Treatment period of the study will transition into the Active Extension period upon completion of the Week 8 visit assessments All subjects in the Active Extension will receive difelikefalin CR845
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