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Gabapentin - A Solution to Uremic Pruritus?

H

Hospital Authority, Hong Kong

Status

Unknown

Conditions

Uremia
Pruritus

Treatments

Drug: Gabapentin

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00577967
355/05
HARECCTR0500020

Details and patient eligibility

About

To investigate using the drug gabapentin to relieve the intense pruritic sensation associated with chronic renal failure patients undergoing peritoneal dialysis.

Enrollment

80 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult Chinese male and female patients aged > 18 undergoing CAPD for at least 3 months and able to read and understand Chinese
  • Patients experiencing moderate to severe pruritis, defined as persistent, treatment-resistant pruritis considerably impairing sleep or daytime activity. Treatment resistance is defined as no or only partial resolvement of pruritis under current anti-pruritis treatment regimens such as anti-pruritis lotions and anti-histamines.
  • Patients in stable clinical condition in terms of peritoneal dialysis and general health
  • Patients able to understand and answer the SDS questionnaire
  • Patients able to express the sensation of itchiness in the terms of the VAS and the SDS score
  • Patients who are willing to give written informed consent and to participate in and comply with the study protocol

Exclusion criteria

  • Patients with a known history of pruritis or dermatologic disease antedating renal failure.
  • Patients with skin disease other than the usual cutaneous findings of uraemia such as xerosis or ecchymosis.
  • Patients under current treatment with systemic steroids
  • Known history of allergy to Gabapentin
  • Those patients already put on anti-convulsants
  • Unable to give written informed consent for the study
  • Pregnancy or female patients of child-bearing age who are unwilling to use contraception
  • Poor drug compliance
  • Known HIV positivity
  • Active neoplastic disease
  • Those who do not want to participate the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

Yui Pong Siu, Dr

Data sourced from clinicaltrials.gov

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