Completed

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

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What is being tested

Doxepin

+ Gabapentin

Drug
Who is being recruted

From 18 to 80 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: June 2018
See protocol details

Summary

Principal SponsorUniversity of Balamand
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2018

Actual date on which the first participant was enrolled.

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.

Official TitleComparison of Gabapentin With Doxepin in the Management of Uremic Pruritus: Pilot Study
NCT03758079
Principal SponsorUniversity of Balamand
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

14 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
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
10 exclusion criteria prevent from participating
patients with psoriasis, atopic dermatitis or any other condition that can justify the pruritus
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
10 mg Doxepin daily for 4 weeks

Group II

Active Comparator
Gabapentin 100mg after each dialysis session

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Saint George Hospital University Medical Center

Beirut, LebanonOpen Saint George Hospital University Medical Center in Google Maps
CompletedOne Study Center