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Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus

Primary Purpose

Uremic Pruritus

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Pregabalin
Placebo
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uremic Pruritus focused on measuring UREMIC PRURITUS, PREGABALIN, UP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shaare Zedek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Pregabalin

Arm Description

Placebo versus pregabalin

Placebo versus pregabalin

Outcomes

Primary Outcome Measures

Reduction of UP by more than 50% after Pregabalin administration

Secondary Outcome Measures

Reduction of chronic pain of various origin and improvement in insomnia after Pregabalin administration

Full Information

First Posted
February 17, 2010
Last Updated
February 22, 2010
Sponsor
Shaare Zedek Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01073501
Brief Title
Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus
Official Title
Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shaare Zedek Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremic Pruritus
Keywords
UREMIC PRURITUS, PREGABALIN, UP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo versus pregabalin
Arm Title
Pregabalin
Arm Type
Experimental
Arm Description
Placebo versus pregabalin
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduction of UP by more than 50% after Pregabalin administration
Time Frame
2012
Secondary Outcome Measure Information:
Title
Reduction of chronic pain of various origin and improvement in insomnia after Pregabalin administration
Time Frame
2012

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LINDA SHAVIT, MD
Phone
97226555086
Email
lshavit@szmc.org.il
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LINDA SHAVIT, MD
Phone
97226555086
Email
lshavit@szmc.org.il
First Name & Middle Initial & Last Name & Degree
linda shavit, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33283264
Citation
Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Results Reference
derived

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Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus

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