Gabapentin - A Solution to Uremic Pruritus?
To investigate using the drug gabapentin to relieve the intense pruritic sensation associated with chronic renal failure patients undergoing peritoneal dialysis...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Gabapentin
Outcome Measures for this Clinical Trial
Primary Measures
- Subjective measurement of reduction in pruritus
- Time Frame: 3 months
- Time Frame: 3 months
Secondary Measures
- Tolerability of Gabapentin in CAPD patients
- Time Frame: 3 months
- Time Frame: 3 months
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Hospital Authority, Hong Kong Other
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
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00577967
