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Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03758079
Recruitment Status : Completed
First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Julien Bachour, MD, University of Balamand

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

Condition or disease Intervention/treatment Phase
Uremic Pruritus Drug: Doxepin Drug: Gabapentin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus: Pilot Study
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : October 8, 2018
Actual Study Completion Date : October 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arm Intervention/treatment
Active Comparator: Doxepin
10 mg Doxepin daily for 4 weeks
Drug: Doxepin
10 mg Doxepin for 4 weeks
Other Names:
  • Silenor
  • Sinequan
  • 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:
  • Neurontin
  • Gralise
  • Gabarone
  • Fanatrex




Primary Outcome Measures :
  1. Change from baseline in Worst-itching Visual Analog Scale (VAS) at week 4 [ Time Frame: 1, 2, 4 weeks ]
    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.

  2. Change from baseline in 5-D Itch Scale score at week 4 [ Time Frame: 1, 2, 4 weeks ]
    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

  3. Change from baseline in Dermatology life quality index (DLQI) at week 4 [ Time Frame: 1, 2, 4 weeks ]
    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.


Secondary Outcome Measures :
  1. side effects of each treatment [ Time Frame: 4 weeks ]
    Number of patients who report side effects while on each treatment



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758079


Locations
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Lebanon
Saint George Hospital University Medical Center
Beirut, Lebanon
Sponsors and Collaborators
University of Balamand
Investigators
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Principal Investigator: Roger N Haber, MD University of Balamand/Saint George Hospital University Medical Center
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Responsible Party: Julien Bachour, MD, Principle Investigator, University of Balamand
ClinicalTrials.gov Identifier: NCT03758079    
Other Study ID Numbers: 064-17/717
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations
Gabapentin
Doxepin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Antidepressive Agents, Tricyclic
Antidepressive Agents
Histamine Antagonists
Histamine Agents