Overview

Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus

Status:
Completed
Trial end date:
2018-10-08
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Balamand
Treatments:
Doxepin
Gabapentin
gamma-Aminobutyric Acid
Criteria
Inclusion Criteria:

- prevalent patients undergoing HD with UP for at least three months

- any medications with antipruritic effects to be discontinued one week before the study

- Hemodialysis performed for 3-4 h thrice weekly via a low flux polysulphonedialyser
[1.3-1.6 m2 surface areas] using bicarbonate and/or acetate dialysis fluid

- well controlled Calcium, Phosphorus and iPTH levels

Exclusion Criteria:

- patients labeled high risk of fall (Having a score more than 16/20 using part 1 from
Falls Risk Assessment Tool (FRAT)

- patients taking drugs that interact with doxepin or gabapentin

- patients with hepatic failure

- patients with hyperthyroidism

- patients with narrow angle glaucoma

- patients with heart block or decompensated heart failure or hypotension (defined as
systolic blood pressure less than 90 mmHg) or myocardial infarction in the past three
months

- history of allergy to gabapentin or doxepin

- uncontrolled psychiatric diseases

- pregnant patients

- patients with psoriasis, atopic dermatitis or any other condition that can justify the
pruritus