Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus

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

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

Study Overview

• Status: Completed
• Conditions: Uremic Pruritus
• Intervention / Treatment: Drug: Doxepin; Drug: Gabapentin

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Saint George Hospital University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Doxepin; 10 mg Doxepin daily for 4 weeks	Drug: Doxepin; 10 mg Doxepin for 4 weeks; Other Names: Sinequan; Silenor; Adapin
Active Comparator: Gabapentin; Gabapentin 100mg after each dialysis session	Drug: Gabapentin; dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks; Other Names: Gralise; Neurontin; Gabarone; Fanatrex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Worst-itching Visual Analog Scale (VAS) at week 4	a 10cm horizontal line marked from zero (no pruritus) to 10 (worst possible pruritus). The pruritus will be assessed subjectively and scored as follows: no pruritus (VAS score 0), mild (VAS score 1-3) with episodic and localized pruritus without disturbance in usual work and sleep, moderate (VAS score 4-7) with generalized and continuous pruritus without sleep disturbance and severe (VAS score 8-10) with generalized, continuous pruritus and sleep disturbance.	1, 2, 4 weeks
Change from baseline in 5-D Itch Scale score at week 4	multidimensional questionnaire. The five dimensions are degree, duration, direction, disability and distribution. The scores of each of the five domains will be achieved separately and then summed together to obtain a total 5-D score ranging between five (no pruritus) and 25 (most severe pruritus). For the distribution domain, the number of affected body parts is tallied (potential sum 0-16) and the sum is sorted into five scoring bins: sum of 0-21⁄4score of 1, sum of 3-51⁄4score of 2, sum of 6-101⁄4score of 3, sum of 11-131⁄4score of 4 and sum of 14-161⁄4score of 5	1, 2, 4 weeks
Change from baseline in Dermatology life quality index (DLQI) at week 4	10-Item questionnaire evaluating: impact of skin condition on HRQoL during the past week, symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment. A Score range from 0 to 30.	1, 2, 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
side effects of each treatment	Number of patients who report side effects while on each treatment	4 weeks

Collaborators and Investigators

• Sponsor: University of Balamand
• Investigators: Principal Investigator: Roger N Haber, MD, University of Balamand/Saint George Hospital University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): October 8, 2018
• Study Completion (Actual): October 8, 2018

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (Actual): November 29, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Hypnotics and Sedatives; Anti-Anxiety Agents; Anticonvulsants; Antidepressive Agents, Tricyclic; Antimanic Agents; Sleep Aids, Pharmaceutical; Histamine Antagonists; Histamine Agents; Gabapentin; Doxepin
• Other Study ID Numbers: 064-17/717

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes