Gabapentin to Treat Itch in Patients With Liver Disease

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Gabapentin; gamma-Aminobutyric Acid

Criteria

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