Cirrhosis Clinical Trial
Official title:
Study of Gabapentin for the Pruritus of Cholestasis
Verified date | October 2017 |
Source | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, the effect of the medication gabapentin to treat itching secondary to liver
disease is being studied.
There are some funds to cover travel expenses for patients who are not from New York (NY).
Gabapentin is approved to treat seizures in human beings. In this study, patients with liver
disease who meet inclusion criteria are admitted to the research hospital of the New York
Presbyterian Hospital to record scratching behavior by the use of a machine designed for that
purpose. Blood work will be obtained. After completion of recording, patients are assigned by
chance to receive active medication or placebo (a capsule that does not contain active
medication). The patients will come to the outpatient office of the research hospital 2 weeks
into the study for an interview and blood work. After 4 weeks, patients are readmitted to the
hospital to record scratching behavior. After data are collected, the code is broken, if
patient had been on inactive drug, active drug will be supplied as per protocol for 4 weeks.
Blood work will be obtained. If patient had been randomized to active medication, the study
will provide one week supply of drug. After that, the referring physician, with whom the
study was previously discussed, could prescribe the medication as it is available.
Status | Completed |
Enrollment | 15 |
Est. completion date | January 2004 |
Est. primary completion date | January 2004 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University College of Physicians and Surgeons | New York | New York |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Bergasa NV, McGee M, Ginsburg IH, Engler D. Gabapentin in patients with the pruritus of cholestasis: a double-blind, randomized, placebo-controlled trial. Hepatology. 2006 Nov;44(5):1317-23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in scratching activity monitoring system | A scratching activity monitoring system specifically designed to record scratching behavior independent of gross body movement | 4 weeks | |
Secondary | Change in visual analogue scale for pruritus | 4 weeks |
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