Gabapentin - A Solution to Uremic Pruritus?
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Hospital Authority, Hong Kong
Collaborator:
Pfizer
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00577967
First received: December 19, 2007
Last updated: July 6, 2010
Last verified: July 2010
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Purpose
To investigate using the drug gabapentin to relieve the intense pruritic sensation associated with chronic renal failure patients undergoing peritoneal dialysis.
| Condition | Intervention |
|---|---|
|
Pruritus Uremia |
Drug: Gabapentin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Gabapentin - A Solution to Uremic Pruritus? A Prospective, Randomized, Placebo-controlled, Double-blind Study |
Resource links provided by NLM:
Further study details as provided by Hospital Authority, Hong Kong:
Eligibility| Genders Eligible for Study: | Both |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577967
Contacts
| Contact: Yui Pong Siu, Dr | (852) 2468 5750 | maryvil@netivigator.com |
Locations
| China | |
| Tuen Mun Hospital | Not yet recruiting |
| Hong Kong, China | |
| Sub-Investigator: Ka Hang Tong, Dr | |
| Sub-Investigator: Kay Tai Leung, Dr | |
| Sub-Investigator: Tze Hoi Kwan, Dr | |
| Sub-Investigator: Tak Cheung Au, Dr | |
Sponsors and Collaborators
Hospital Authority, Hong Kong
Pfizer
Investigators
| Principal Investigator: | Yui Pong Siu, Dr | Medical and Geriatrics / Nephrology, Tuen Mun Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00577967 History of Changes |
| Other Study ID Numbers: | 355/05, HARECCTR0500020 |
| Study First Received: | December 19, 2007 |
| Last Updated: | July 6, 2010 |
| Health Authority: | Hong Kong: Ethics Committee |
Keywords provided by Hospital Authority, Hong Kong:
|
Uremic pruritis |
Additional relevant MeSH terms:
|
Pruritus Uremia Skin Diseases Skin Manifestations Signs and Symptoms Kidney Diseases Urologic Diseases Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents |
ClinicalTrials.gov processed this record on May 19, 2013