Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus
Information source: Shaare Zedek Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Uremic Pruritus
Intervention: Pregabalin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Shaare Zedek Medical Center Overall contact: LINDA SHAVIT, MD, Phone: 97226555086, Email: lshavit@szmc.org.il
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.
Clinical Details
Official title: Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
LINDA SHAVIT, MD, Phone: 97226555086, Email: lshavit@szmc.org.il
Shaare Zedek Medical Center, Jerusalem 91031, Israel; Not yet recruiting LINDA SHAVIT, MD, Phone: 97226555086, Email: lshavit@szmc.org.il linda shavit, MD, Principal Investigator
Additional Information
Starting date: April 2010
Last updated: February 22, 2010
|