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Gabapentin - A Solution to Uremic Pruritus?
This study is not yet open for participant recruitment.
Verified by Hospital Authority, Hong Kong, June 2008
Sponsors and Collaborators: Hospital Authority, Hong Kong
Pfizer
Information provided by: Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier: NCT00577967
  Purpose

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


Condition Intervention
Pruritus
Uremia
Drug: Gabapentin

MedlinePlus related topics: Itching Kidney Failure
Drug Information available for: Gabapentin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Gabapentin - A Solution to Uremic Pruritus? A Prospective, Randomized, Placebo-Controlled, Double-Blind Study

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • Subjective measurement of reduction in pruritus [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Tolerability of Gabapentin in CAPD patients [ Time Frame: 3 months ]

Estimated Enrollment: 80
Study Start Date: October 2005
Estimated Study Completion Date: March 2006
  Eligibility

Genders Eligible for Study:   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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577967

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

Locations
China
Tuen Mun Hospital
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
Pfizer
Investigators
Principal Investigator: Yui Pong Siu, Dr Medical and Geriatrics / Nephrology, Tuen Mun Hospital
  More Information

HAREC Clinical Trial Registry  This link exits the ClinicalTrials.gov site

Study ID Numbers: 355/05, HARECCTR0500020
Study First Received: December 19, 2007
Last Updated: December 15, 2008
ClinicalTrials.gov Identifier: NCT00577967  
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
Uremic pruritis

Study placed in the following topic categories:
Pruritus
Excitatory Amino Acids
Calcium, Dietary
Signs and Symptoms
Skin Diseases
Gabapentin
Uremia

Additional relevant MeSH terms:
Skin Manifestations
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Membrane Transport Modulators
Sensory System Agents
Therapeutic Uses
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009