Gabapentin - A Solution to Uremic Pruritus?

NCT00577967 | Unknown

• 2 other identifiers: 355/05HARECCTR0500020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pruritus; Uremia

Keywords

Uremic pruritis

Outcome Measures

Primary Outcomes (1)

• Subjective measurement of reduction in pruritus

  3 months

Secondary Outcomes (1)

• Tolerability of Gabapentin in CAPD patients

  3 months

Interventions

Gabapentin DRUG

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead
• Pfizer: collaborator

Study Sites (1)

Tuen Mun Hospital

Hong Kong, China

Location

Related Publications (1)

• 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.

  PMID: 33283264 DERIVED

MeSH Terms

Conditions

Pruritus; Uremia

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Yui Pong Siu, Dr

  Medical and Geriatrics / Nephrology, Tuen Mun Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yui Pong Siu, Dr

CONTACT

(852) 2468 5750; maryvil@netivigator.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 20, 2007
• Study Start: October 1, 2005
• Study Completion: March 1, 2006
• Last Updated: July 7, 2010

Record last verified: 2010-07

Locations

CN (1)