Gabapentin - A Solution to Uremic Pruritus?

Not Applicable

• Conditions: Pruritus; Uremia

• Registration Number: NCT00577967
• Lead Sponsor: Hospital Authority, Hong Kong

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study Completion: 2006-03
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-20
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-06
• Last Update Posted: 2010-07-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Subjective measurement of reduction in pruritus	3 months

Secondary Outcome Measures

Name	Time	Method
Tolerability of Gabapentin in CAPD patients	3 months

Trial Locations

Locations (1)

Tuen Mun Hospital; 🇨🇳 Hong Kong, China