Pruritus Clinical Trial
Official title:
Gabapentin - A Solution to Uremic Pruritus? A Prospective, Randomized, Placebo-controlled, Double-blind Study
To investigate using the drug gabapentin to relieve the intense pruritic sensation associated with chronic renal failure patients undergoing peritoneal dialysis.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | March 2006 |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Tuen Mun Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Hospital Authority, Hong Kong | Pfizer |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subjective measurement of reduction in pruritus | 3 months | ||
Secondary | Tolerability of Gabapentin in CAPD patients | 3 months |
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