Uremic Pruritus
Conditions
Keywords
UREMIC PRURITUS, PREGABALIN, UP
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.
Interventions
DRUGPregabalin
Pregabalin 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
DRUGPlacebo
Pregabalin 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
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of UP by more than 50% after Pregabalin administration | 2012 |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of chronic pain of various origin and improvement in insomnia after Pregabalin administration | 2012 |
Countries
Israel
Contacts
Primary ContactLINDA SHAVIT, MD
Outcome results
None listed