Official Title: “Gabapentin - A Solution to Uremic Pruritus? A Prospective, Randomized, Placebo-Controlled, Double-Blind Study”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Gabapentin

Primary Measures

• Subjective measurement of reduction in pruritus
  • Time Frame: 3 months
    

Secondary Measures

• Tolerability of Gabapentin in CAPD patients
  • Time Frame: 3 months
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Hospital Authority, Hong Kong

Overall Clinical Trial Officials and Contacts

Yui Pong Siu, Dr Principal Investigator Medical and Geriatrics / Nephrology, Tuen Mun Hospital  

Overall Contact: Yui Pong Siu, Dr (852) 2468 5750 maryvil@netivigator.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00577967

Study ID Number: 355/05

ClinicalTrials.gov Identifier: NCT00577967

Health Authority: Hong Kong: Ethics Committee

HAREC Clinical Trial Registry