NCT03758079

Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus

Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus: Pilot Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Balamand · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a single blind randomized trial to compare efficacy and side effects of Gabapentin with Doxepin. Hemodialysis patients with uremic pruritus at one dialysis center of Saint George Hospital University Medical Centre were included in this study. Patients were divided into 2 groups to receive either 10 mg Doxepin daily or Gabapentin at a dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks, after which patients were treated reversley. Pruritus severity and its effect on quality of life will be assessed by using visual analog scale (VAS), 5-D pruritus scale and dermatology life quality index (DLQI). Include patients will have to fill these forms at baseline and at end of week1, week2 and week4

Detailed description

Pruritus is one of the frustrating skin manifestations of advanced renal failure. Many options have been used for the management of uremic pruritus (UP) such as Pregabalin, Gabapentin, Doxepine and Desloratidine. Gabapentin, a GABAergic drug, has been found to be effective in the treatment of uremic pruritus. Doxepin, a potent antihistamine drug, is used orally or topically in many pruritic conditions such as UP, idiopathic pruritus, atopic dermatitis, neurogenic, or psychogenic pruritus and, in the management of the UP in hemodialysis patients. No comparative head to head study between Gabapentin and Doxepine has been conducted to date. The aim of this study was to compare Gabapentin and Doxepin in treatment of uremic pruritus in hemodialysis patients.

Conditions

• Uremic Pruritus

Interventions

Type	Name	Description
DRUG	Doxepin	10 mg Doxepin for 4 weeks
DRUG	Gabapentin	dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks

Timeline

• Start date: 2018-06-01
• Primary completion: 2018-10-08
• Completion: 2018-10-08
• First posted: 2018-11-29
• Last updated: 2018-11-29

Locations

1 site across 1 country: Lebanon

Regulatory

• FDA-regulated drug study