Gabapentin - A Solution to Uremic Pruritus?

• Sponsor: Hospital Authority, Hong Kong (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00577967
• Collaborator: Pfizer (Industry)
• Enrollment: 80
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 16.1

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Oct 1, 2005
• Anticipated Study Completion Date: Mar 1, 2006

Outcome Measures

Primary Outcome Measures

1. Subjective measurement of reduction in pruritus [3 months]

Secondary Outcome Measures

1. Tolerability of Gabapentin in CAPD patients [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• HAREC Clinical Trial Registry

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00577967
• Other Study ID Numbers: 355/05; HARECCTR0500020
• First Posted: Dec 20, 2007
• Last Update Posted: Jul 7, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Uremic pruritis
• Additional relevant MeSH terms: Pruritus; Gabapentin

Study Results

No Results Posted as of Jul 7, 2010