Clinical Trial: Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus

Brief 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.

Detailed Summary:
Sponsor: Shaare Zedek Medical Center

Current Primary Outcome: Reduction of UP by more than 50% after Pregabalin administration [ Time Frame: 2012 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Reduction of chronic pain of various origin and improvement in insomnia after Pregabalin administration [ Time Frame: 2012 ]

Original Secondary Outcome: Same as current

Information By: Shaare Zedek Medical Center

Dates:
Date Received: February 17, 2010
Date Started: April 2010
Date Completion: March 2012
Last Updated: February 22, 2010
Last Verified: February 2010