Gabapentin - A Solution to Uremic Pruritus?
Overview[ - collapse ][ - ]
| Purpose | To investigate using the drug gabapentin to relieve the intense pruritic sensation associated with chronic renal failure patients undergoing peritoneal dialysis. |
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| Condition | Pruritus Uremia |
| Intervention | Drug: Gabapentin |
| Phase | N/A |
| Sponsor | Hospital Authority, Hong Kong |
| Responsible Party | Hospital Authority, Hong Kong |
| ClinicalTrials.gov Identifier | NCT00577967 |
| First Received | December 19, 2007 |
| Last Updated | July 6, 2010 |
| Last verified | July 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 19, 2007 |
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| Last Updated Date | July 6, 2010 |
| Start Date | October 2005 |
| Estimated Primary Completion Date | March 2006 |
| Current Primary Outcome Measures | Subjective measurement of reduction in pruritus [Time Frame: 3 months] |
| Current Secondary Outcome Measures | Tolerability of Gabapentin in CAPD patients [Time Frame: 3 months] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Gabapentin - A Solution to Uremic Pruritus? |
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| Official Title | 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 | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Gabapentin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
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| Estimated Enrollment | 80 |
| Estimated Completion Date | March 2006 |
| Estimated Primary Completion Date | Not Provided |
| 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 |
| Gender | Both |
| Ages | N/A |
| Accepts Healthy Volunteers | Not Provided |
| Contacts | Contact: Yui Pong Siu, Dr (852) 2468 5750 maryvil@netivigator.com |
| Location Countries | China |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00577967 |
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| Other Study ID Numbers | 355/05 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Hospital Authority, Hong Kong |
| Study Sponsor | Hospital Authority, Hong Kong |
| Collaborators | Pfizer |
| Investigators | Principal Investigator: Yui Pong Siu, Dr Medical and Geriatrics / Nephrology, Tuen Mun Hospital |
| Verification Date | July 2010 |
Locations[ + expand ][ + ]
| Tuen Mun Hospital | Hong Kong, China Sub-Investigator: Ka Hang Tong, DrNot yet recruiting |
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