Gabapentin - A Solution to Uremic Pruritus?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00577967
First received: December 19, 2007
Last updated: July 6, 2010
Last verified: July 2010
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Gabapentin - A Solution to Uremic Pruritus? A Prospective, Randomized, Placebo-controlled, Double-blind Study

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Not yet recruiting
Hong Kong, China
Sub-Investigator: Ka Hang Tong, Dr         
Sub-Investigator: Kay Tai Leung, Dr         
Sub-Investigator: Tze Hoi Kwan, Dr         
Sub-Investigator: Tak Cheung Au, Dr         
Sponsors and Collaborators
Hospital Authority, Hong Kong
Pfizer
Investigators
Principal Investigator: Yui Pong Siu, Dr Medical and Geriatrics / Nephrology, Tuen Mun Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00577967     History of Changes
Other Study ID Numbers: 355/05, HARECCTR0500020
Study First Received: December 19, 2007
Last Updated: July 6, 2010
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
Uremic pruritis

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

ClinicalTrials.gov processed this record on July 24, 2014