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Gabapentin - A Solution to Uremic Pruritus?

Gabapentin - A Solution to Uremic Pruritus? A Prospective, Randomized, Placebo-controlled, Double-blind Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00577967
Enrollment
80
Registered
2007-12-20
Start date
2005-10-31
Completion date
2006-03-31
Last updated
2010-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pruritus, Uremia

Keywords

Uremic pruritis

Brief summary

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

Interventions

DRUGGabapentin

Sponsors

Pfizer
CollaboratorINDUSTRY
Hospital Authority, Hong Kong
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
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

Design outcomes

Primary

MeasureTime frame
Subjective measurement of reduction in pruritus3 months

Secondary

MeasureTime frame
Tolerability of Gabapentin in CAPD patients3 months

Countries

China

Contacts

Primary ContactYui Pong Siu, Dr
maryvil@netivigator.com(852) 2468 5750

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026