Gabapentin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Pruritus Uremia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No