Gabapentin - A Solution to Uremic Pruritus?
Information source: Hospital Authority, Hong Kong
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pruritus; Uremia
Intervention: Gabapentin (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Hospital Authority, Hong Kong Official(s) and/or principal investigator(s):
Yui Pong Siu, Dr, Principal Investigator, Affiliation: Medical and Geriatrics / Nephrology, Tuen Mun Hospital
Overall contact:
Yui Pong Siu, Dr, Phone: (852) 2468 5750, Email: maryvil@netivigator.com
Summary
To investigate using the drug gabapentin to relieve the intense pruritic sensation
associated with chronic renal failure patients undergoing peritoneal dialysis.
Clinical Details
Official title: Gabapentin - A Solution to Uremic Pruritus? A Prospective, Randomized, Placebo-Controlled, Double-Blind Study
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Subjective measurement of reduction in pruritus
Secondary outcome: Tolerability of Gabapentin in CAPD patients
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Yui Pong Siu, Dr, Phone: (852) 2468 5750, Email: maryvil@netivigator.com
Tuen Mun Hospital, Hong Kong, China
Additional Information
HAREC Clinical Trial Registry
Starting date: October 2005
Ending date: March 2006
Last updated: June 23, 2009
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