Gabapentin - A Solution to Uremic Pruritus?

NCT00577967

Last updated date
Study Location
Tuen Mun Hospital
Hong Kong, , , China
Contact
(852) 2468 5750

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pruritus, Uremia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Pruritus, UremiaGabapentin - A Solution to Uremic Pruritus?
NCT00577967
  1. Hong Kong,
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Gabapentin - A Solution to Uremic Pruritus?
Official Title  ICMJE Gabapentin - A Solution to Uremic Pruritus? A Prospective, Randomized, Placebo-controlled, Double-blind Study
Brief Summary To investigate using the drug gabapentin to relieve the intense pruritic sensation associated with chronic renal failure patients undergoing peritoneal dialysis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Pruritus
  • Uremia
Intervention  ICMJE Drug: Gabapentin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 19, 2007)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00577967
Other Study ID Numbers  ICMJE 355/05
HARECCTR0500020
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hospital Authority, Hong Kong
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Yui Pong Siu, DrMedical and Geriatrics / Nephrology, Tuen Mun Hospital
PRS Account Hospital Authority, Hong Kong
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP