Ignite Creation Date:
2024-05-06 @ 2:51 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02143648
Status:
COMPLETED
Last Update Posted:
2020-09-07
First Post:
2014-05-17
Brief Title:
Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
Sponsor:
Trevi Therapeutics
Organization:
Trevi Therapeutics
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel 3-Arm Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
Status:
COMPLETED
Status Verified Date:
2020-08
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:
The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale NRS in hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and tolerability in the study population
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-005625-22 | EUDRACT_NUMBER | None | None |