Gabapentin - A Solution to Uremic Pruritus?

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

HAREC Clinical Trial Registry 

ClinicalTrials.gov Identifier:	NCT00577967 History of Changes
Other Study ID Numbers:	355/05; HARECCTR0500020
First Posted:	December 20, 2007
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