Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus

Study Overview
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Brief Summary
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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.

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

Conditions
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Uremic Pruritus

Intervention / Treatment
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* Drug: Pregabalin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of pruritus of >8 weeks duration. Severity of pruritus of 7 or more defined by visual analogue scale. No improvement by oral antihistamines or skin moisturizers. Discontinuation of any medication with presumed antipruritic effects at least 1 week before the study. Negative pregnancy test result for all participating women of childbearing age; Exclusion Criteria: Known allergy to Pregabalin Any acute illness; Liver cirrhosis Active dermatological disorder other than UP Decompensated heart failure; Inability to give informed consent; Poor compliance.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo versus pregabalin | Drug: Placebo<br>* 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<br>|
| Experimental: Pregabalin<br>Placebo versus pregabalin | Drug: Pregabalin<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of UP by more than 50% after Pregabalin administration |  | 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of chronic pain of various origin and improvement in insomnia after Pregabalin administration |  | 2012 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UREMIC PRURITUS, PREGABALIN, UP