A Phase 4 interventional study of Doxepin and Gabapentin in Uremic Pruritus, sponsored by University of Balamand. Completed at 1 site in Lebanon. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-11-29.
Sponsored by University of Balamand · Phase 4, Interventional, and Treatment
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
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.
University of Balamand is the lead sponsor of 4 studies on the registry; none are open to participants now.
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10 mg Doxepin daily for 4 weeks
Drug: Doxepin
Gabapentin 100mg after each dialysis session
Drug: Gabapentin
10 mg Doxepin for 4 weeks
Also known as: Silenor, Sinequan, Adapin
dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks
Also known as: Neurontin, Gralise, Gabarone, Fanatrex
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.
Time frame: 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
Time frame: 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.
Time frame: 1, 2, 4 weeks
side effects of each treatment
Number of patients who report side effects while on each treatment
Time frame: 4 weeks
Plan to share: Undecided
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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Doxepin · Gabapentin
University of Balamand