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Clinical Trial Summary

Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced or end-stage renal disease. Its intensity ranges from sporadic discomfort to complete restlessness during both the day- and night-time and its distribution varies significantly over time. Many attempts have been made to relieve this bothersome symptom in affected patients, however with generally limited success. Incidence of UP varies widely between studies and seems to decline over the last 30 years (from 85% in the 1970s and 50-60% in the 1980s to a 22% in the 2000s) (Gunal AI).

We use Pregabalin for the relief of diabetic neuropathic pain in patients on haemodialysis in our centre. In addition to neuropathic pain, several of our patients have complained of pruritus and after Pregabalin treatment, their pruritus has promptly and completely resolved. Accordingly, we intend to conduct a double-blind, placebo-controlled, crossover trial to assess the effectiveness of Pregabalin in chronic UP.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01073501
Study type Interventional
Source Shaare Zedek Medical Center
Contact LINDA SHAVIT, MD
Phone 97226555086
Email lshavit@szmc.org.il
Status Not yet recruiting
Phase Phase 4
Start date April 2010
Completion date March 2012

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