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Gabapentin - A Solution to Uremic Pruritus?

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ClinicalTrials.gov Identifier: NCT00577967
Recruitment Status : Unknown
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was:  Not yet recruiting
First Posted : December 20, 2007
Last Update Posted : July 7, 2010
Sponsor:
Collaborator:
Pfizer
Information provided by:
Hospital Authority, Hong Kong

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

Condition or disease Intervention/treatment Phase
Pruritus Uremia Drug: Gabapentin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Gabapentin - A Solution to Uremic Pruritus? A Prospective, Randomized, Placebo-controlled, Double-blind Study
Study Start Date : October 2005
Estimated Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Subjective measurement of reduction in pruritus [ Time Frame: 3 months ]

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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Additional Information:
HAREC Clinical Trial Registry  This link exits the ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT00577967     History of Changes
Other Study ID Numbers: 355/05
HARECCTR0500020
First Posted: December 20, 2007    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010

Keywords provided by Hospital Authority, Hong Kong:
Uremic pruritis

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