| Trial ID: | L1411 |
| Source ID: | NCT06466421
|
| Associated Drug: |
Fexofenadine
|
| Title: |
Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis
|
| Acronym: |
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Uremic Pruritus|Chronic Kidney Disease-associated Pruritus|Hemodialysis|End-stage Renal Disease|Renal Replacement Therapy|ESRD
|
| Interventions: |
DRUG: Fexofenadine|DRUG: Gabapentin
|
| Outcome Measures: |
Primary: The Visual Analogue Scale (VAS), The change in mean score of Visual Analogue Scale (VAS) from baseline., 3 months|Skindex score, The change in mean Skindex score from baseline., 3 months|Kidney Disease Quality of Life Short Form (KDQOL-SF™), The change in mean KDQOL-SF score from baseline., 3 months | Secondary: Interleukin-6 (IL-6), The change in mean serum level of Interleukin-6 (IL-6) from baseline., 3 months|Substance P, The change in mean serum level of Substance P from baseline., 3 months
|
| Sponsor/Collaborators: |
Sponsor: Tanta University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-07-01
|
| Completion Date: |
2024-12-20
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-19
|
| Locations: |
Tanta University, Tanta, Elgharbia, 31527, Egypt
|
| URL: |
https://clinicaltrials.gov/show/NCT06466421
|
