Gabapentin - A Solution to Uremic Pruritus?
Primary Purpose
Pruritus, Uremia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Gabapentin
Sponsored by
About this trial
This is an interventional treatment trial for Pruritus focused on measuring Uremic pruritis
Eligibility Criteria
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
Sites / Locations
- Tuen Mun Hospital
Outcomes
Primary Outcome Measures
Subjective measurement of reduction in pruritus
Secondary Outcome Measures
Tolerability of Gabapentin in CAPD patients
Full Information
NCT ID
NCT00577967
First Posted
December 19, 2007
Last Updated
July 6, 2010
Sponsor
Hospital Authority, Hong Kong
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00577967
Brief Title
Gabapentin - A Solution to Uremic Pruritus?
Official Title
Gabapentin - A Solution to Uremic Pruritus? A Prospective, Randomized, Placebo-controlled, Double-blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
Pfizer
4. Oversight
5. Study Description
Brief Summary
To investigate using the drug gabapentin to relieve the intense pruritic sensation associated with chronic renal failure patients undergoing peritoneal dialysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus, Uremia
Keywords
Uremic pruritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Primary Outcome Measure Information:
Title
Subjective measurement of reduction in pruritus
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Tolerability of Gabapentin in CAPD patients
Time Frame
3 months
10. Eligibility
Sex
All
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yui Pong Siu, Dr
Phone
(852) 2468 5750
Email
maryvil@netivigator.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yui Pong Siu, Dr
Organizational Affiliation
Medical and Geriatrics / Nephrology, Tuen Mun Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ka Hang Tong, Dr
First Name & Middle Initial & Last Name & Degree
Kay Tai Leung, Dr
First Name & Middle Initial & Last Name & Degree
Tze Hoi Kwan, Dr
First Name & Middle Initial & Last Name & Degree
Tak Cheung Au, Dr
12. IPD Sharing Statement
Citations:
PubMed Identifier
33283264
Citation
Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Results Reference
derived
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Gabapentin - A Solution to Uremic Pruritus?
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