Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus
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|ClinicalTrials.gov Identifier: NCT03758079|
Recruitment Status : Completed
First Posted : November 29, 2018
Last Update Posted : November 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Uremic Pruritus||Drug: Doxepin Drug: Gabapentin||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Active Comparator: Doxepin
10 mg Doxepin daily for 4 weeks
10 mg Doxepin for 4 weeks
Active Comparator: Gabapentin
Gabapentin 100mg after each dialysis session
dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks
- 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.
- 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
- 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.
- side effects of each treatment [ Time Frame: 4 weeks ]Number of patients who report side effects while on each treatment
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
|Saint George Hospital University Medical Center|
|Principal Investigator:||Roger N Haber, MD||University of Balamand/Saint George Hospital University Medical Center|