Ignite Creation Date:
2024-07-17 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466421
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-07
Brief Title:
Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis
Sponsor:
Tanta University
Organization:
Tanta University
Study Overview
Official Title:
Clinical Study to Compare The Safety and Possible Efficacy of Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
Several studies investigated the effectiveness of Gabapentin in Uremic Pruritus UP No previous studies investigated the use of fexofenadine in UP The aim of this trial is to assess the safety and possible efficacy of fexofenadine in patients with UP
Detailed Description:
A randomized controlled single center parallel study that will recruit 60 participants with end stage renal disease ESRD on regular hemodialysis RHD with uremic pruritus UP Patients will be randomized to either Fexofenadine 60 mg orally once daily or Gabapentin 100 mg orally after each dialysis session thrice weekly with titration according to response to 100 mg orally once daily Participants will continue treatment for 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None