Back to resultsComparison of Gabapentin With Doxepin in the Management of Uremic Pruritus
Primary Purpose
Uremic Pruritus
Status
Completed
Phase
Phase 4
Locations
Lebanon
Study Type
Interventional
Intervention
Doxepin
Gabapentin
Sponsored by
About this trial
This is an interventional treatment trial for Uremic Pruritus
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
Sites / Locations
- Saint George Hospital University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Doxepin
Gabapentin
Arm Description
10 mg Doxepin daily for 4 weeks
Gabapentin 100mg after each dialysis session
Outcomes
Primary Outcome Measures
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.
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
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.
Secondary Outcome Measures
side effects of each treatment
Number of patients who report side effects while on each treatment
Full Information
NCT ID
NCT03758079
First Posted
November 19, 2018
Last Updated
November 28, 2018
Sponsor
University of Balamand
1. Study Identification
Unique Protocol Identification Number
NCT03758079
Brief Title
Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus
Official Title
Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
October 8, 2018 (Actual)
Study Completion Date
October 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Balamand
4. Oversight
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
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremic Pruritus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Doxepin
Arm Type
Active Comparator
Arm Description
10 mg Doxepin daily for 4 weeks
Arm Title
Gabapentin
Arm Type
Active Comparator
Arm Description
Gabapentin 100mg after each dialysis session
Intervention Type
Drug
Intervention Name(s)
Doxepin
Other Intervention Name(s)
Silenor, Sinequan, Adapin
Intervention Description
10 mg Doxepin for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin, Gralise, Gabarone, Fanatrex
Intervention Description
dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks
Primary Outcome Measure Information:
Title
Change from baseline in Worst-itching Visual Analog Scale (VAS) at week 4
Description
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.
Time Frame
1, 2, 4 weeks
Title
Change from baseline in 5-D Itch Scale score at week 4
Description
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
Time Frame
1, 2, 4 weeks
Title
Change from baseline in Dermatology life quality index (DLQI) at week 4
Description
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.
Time Frame
1, 2, 4 weeks
Secondary Outcome Measure Information:
Title
side effects of each treatment
Description
Number of patients who report side effects while on each treatment
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger N Haber, MD
Organizational Affiliation
University of Balamand/Saint George Hospital University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint George Hospital University Medical Center
City
Beirut
Country
Lebanon
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus
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