Uremic Pruritus | Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus
Uremic Pruritus research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 1. History of pruritus of >8 weeks duration. 2. Severity of pruritus of 7 or more defined by visual analogue scale. 3. No improvement by oral antihistamines or skin moisturizers. 4. Discontinuation of any medication with presumed antipruritic effects at least 1 week before the study. 5. Negative pregnancy test result for all participating women of childbearing age; Exclusion Criteria: 1. Known allergy to Pregabalin 2. Any acute illness; 3. Liver cirrhosis 4. Active dermatological disorder other than UP 5. Decompensated heart failure; 6. Inability to give informed consent; 7. Poor compliance.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:PregabalinPregabalin 25 mg (Lyrica; Pfizer, Germany) or placebo will be administered orally daily at the end of hemodialysis sessions in dialysis patients or every evening in non dialysis CKD patients. The dose will be increased up to 50 mg if no improvement of pruritus will be established at the end of first week of the study
Drug:PlaceboPregabalin 25 mg (Lyrica; Pfizer, Germany) or placebo will be administered orally daily at the end of hemodialysis sessions in dialysis patients or every evening in non dialysis CKD patients. The dose will be increased up to 50 mg if no improvement of pruritus will be established at the end of first week of the study
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PlaceboPlacebo versus pregabalin
PregabalinPlacebo versus pregabalin
Start Date: April 2010
Completed Date: March 2012
Phase: Phase 4
Primary Outcome: Reduction of UP by more than 50% after Pregabalin administration
Secondary Outcome: Reduction of chronic pain of various origin and improvement in insomnia after Pregabalin administration
Study sponsors, principal investigator, and references
Lead Sponsor: Shaare Zedek Medical Center