Status:
COMPLETED
Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus
Lead Sponsor:
University of Balamand
Conditions:
Uremic Pruritus
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 Univ...
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 De...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2018
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03758079
Start Date
June 1 2018
End Date
October 8 2018
Last Update
November 29 2018
Active Locations (1)
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1
Saint George Hospital University Medical Center
Beirut, Lebanon