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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00058890 |
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Date of registration:
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14/04/2003 |
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Primary sponsor: |
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Public title:
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Gabapentin to Treat Itch in Patients With Liver Disease
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Scientific title:
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Study of Gabapentin for the Pruritus of Cholestasis |
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Date of first enrolment:
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November 2000 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00058890 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Nora V Bergasa, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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New York Presbyterian Hospital Columbia University College of Physicians and Surgeons |
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Key inclusion & exclusion criteria
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Inclusion criteria include:
- Patients from ages 18 to 80 with chronic pruritus secondary to liver disease
Patients must have:
- a normal chest X- ray during the previous year
- normal thyroid function tests (treated thyroid dysfunction is acceptable)
- controlled diabetes, if diabetes mellitus is present
- negative fecal occult blood within the previous year
Exclusion criteria include:
- history of hepatic encephalopathy
- decompensated liver disease as suggested by ascites and history of variceal bleeding
- malignancy
- inability to practice contraception
- pregnancy
- creatinine > 1.7 mg/dl
- hemoglobin < 10mg/dl
- S/P liver transplantation
- HIV infection
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cholestasis
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Cirrhosis
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Itching
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Liver Disease
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Pruritus
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Intervention(s)
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Drug: gabapentin
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Primary Outcome(s)
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Change in scratching activity monitoring system
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Secondary Outcome(s)
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Change in visual analogue scale for pruritus
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Secondary ID(s)
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R03 --9618 (completed 2005)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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