Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus

NCT ID: NCT03758079

Last Updated: 2018-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2018-10-08

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Doxepin

10 mg Doxepin daily for 4 weeks

Group Type: ACTIVE_COMPARATOR

Doxepin

Intervention Type: DRUG

10 mg Doxepin for 4 weeks

Gabapentin

Gabapentin 100mg after each dialysis session

Group Type: ACTIVE_COMPARATOR

Gabapentin

Intervention Type: DRUG

dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks

Interventions

Doxepin

10 mg Doxepin for 4 weeks

Intervention Type: DRUG

Gabapentin

dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks

Intervention Type: DRUG

Other Intervention Names

Silenor; Sinequan; Adapin; Neurontin; Gralise; Gabarone; Fanatrex

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Balamand

OTHER

Sponsor Role: lead

Responsible Party

Julien Bachour, MD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roger N Haber, MD

Role: PRINCIPAL_INVESTIGATOR

University of Balamand/Saint George Hospital University Medical Center

Locations

Saint George Hospital University Medical Center

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

064-17/717

Identifier Type: -

Identifier Source: org_study_id