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NCT00577967 Clinical Trial

Gabapentin - A Solution to Uremic Pruritus?

Pruritus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00577967
Other study ID # 355/05
Secondary ID HARECCTR0500020
Status Not yet recruiting
Phase N/A
First received December 19, 2007
Last updated July 6, 2010
Start date October 2005
Est. completion date March 2006

Study information
Verified date July 2010
Source Hospital Authority, Hong Kong
Contact Yui Pong Siu, Dr
Phone (852) 2468 5750
Email maryvil@netivigator.com
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Gabapentin

Locations
Country Name City State
China Tuen Mun Hospital Hong Kong

Sponsors (2)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong Pfizer

Country where clinical trial is conducted

China, 

Outcome
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
See also
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Completed NCT02143973 - Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus Phase 2/Phase 3
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