NCT01073501

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

February 23, 2010

Status Verified

February 1, 2010

Enrollment Period

1.9 years

First QC Date

February 17, 2010

Last Update Submit

February 22, 2010

Conditions

Uremic Pruritus

Keywords

UREMIC PRURITUSPREGABALINUP

Outcome Measures

Primary Outcomes (1)

  • Reduction of UP by more than 50% after Pregabalin administration

    2012

Secondary Outcomes (1)

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

    2012

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo versus pregabalin

Drug: Placebo

Pregabalin

EXPERIMENTAL

Placebo versus pregabalin

Drug: Pregabalin

Interventions

PregabalinDRUG

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

Pregabalin
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Related Publications (1)

  • 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.

    PMID: 33283264DERIVED

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Central Study Contacts

LINDA SHAVIT, MD

CONTACT

97226555086lshavit@szmc.org.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2010

First Posted

February 23, 2010

Study Start

April 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

February 23, 2010

Record last verified: 2010-02

Locations

IL(1)