Gabapentin - A Solution to Uremic Pruritus?
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00577967 |
Recruitment Status
: Unknown
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was: Not yet recruiting
First Posted
: December 20, 2007
Last Update Posted
: July 7, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pruritus Uremia | Drug: Gabapentin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Gabapentin - A Solution to Uremic Pruritus? A Prospective, Randomized, Placebo-controlled, Double-blind Study |
Study Start Date : | October 2005 |
Estimated Study Completion Date : | March 2006 |

- Subjective measurement of reduction in pruritus [ Time Frame: 3 months ]
- Tolerability of Gabapentin in CAPD patients [ Time Frame: 3 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577967
Contact: Yui Pong Siu, Dr | (852) 2468 5750 | maryvil@netivigator.com |
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 |
Principal Investigator: | Yui Pong Siu, Dr | Medical and Geriatrics / Nephrology, Tuen Mun Hospital |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00577967 History of Changes |
Other Study ID Numbers: |
355/05 HARECCTR0500020 |
First Posted: | December 20, 2007 Key Record Dates |
Last Update Posted: | July 7, 2010 |
Last Verified: | July 2010 |
Keywords provided by Hospital Authority, Hong Kong:
Uremic pruritis |
Additional relevant MeSH terms:
Pruritus Skin Diseases Skin Manifestations Signs and Symptoms Gabapentin gamma-Aminobutyric Acid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents |
Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents GABA Agents |