Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus

• ClinicalTrials.gov Identifier: NCT03758079
• Recruitment Status: Completed
• First Posted: November 29, 2018
• Last Update Posted: November 29, 2018
• Sponsor: University of Balamand
• Information provided by (Responsible Party): Julien Bachour, MD, University of Balamand

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Lebanon

Saint George Hospital University Medical Center

Beirut, Lebanon

Sponsors and Collaborators

University of Balamand

Investigators

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

More Information

• 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
• Last Update Posted: November 29, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

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