Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus

Phase 4

• Conditions: Uremic Pruritus
• Interventions: Drug: Placebo; Drug: Pregabalin

• Registration Number: NCT01073501
• Lead Sponsor: Shaare Zedek Medical Center

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 Description

Not available

Study Timeline

• Status Verified: 2010-02
• Study First Submitted: 2010-02-17
• Study First Submitted QC: 2010-02-22
• Last Update Submitted: 2010-02-22
• Study First Posted: 2010-02-23
• Last Update Posted: 2010-02-23
• Study Start: 2010-04
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo versus pregabalin
Pregabalin	Pregabalin	Placebo versus pregabalin

Primary Outcome Measures

Name	Time	Method
Reduction of UP by more than 50% after Pregabalin administration	2012

Secondary Outcome Measures

Name	Time	Method
Reduction of chronic pain of various origin and improvement in insomnia after Pregabalin administration	2012

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel