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Pruritus | Gabapentin - A Solution to Uremic Pruritus?

Pruritus research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pruritus

Uremia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Gabapentin

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Unknown status

Start Date: October 2005

Completed Date: March 2006

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Subjective measurement of reduction in pruritus

Secondary Outcome: Tolerability of Gabapentin in CAPD patients

Study sponsors, principal investigator, and references

Principal Investigator: Yui Pong Siu, Dr

Lead Sponsor: Hospital Authority, Hong Kong

Collaborator: Pfizer

More information:https://clinicaltrials.gov/show/NCT00577967

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