Gabapentin to Treat Itch in Patients With Liver Disease

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Overall Status

Completed

CT.gov ID

NCT00058890

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Liver Disease Cholestasis Cirrhosis Pruritus Itching	Drug: Gabapentin Drug: Placebo	Phase 3

Detailed Description

Double-blind, randomized, placebo-controlled study of gabapentin for the pruritus of cholestasis. Duration: 4 weeks. Some travel funds available for patients from out of the NY area for all the visits. Hospitalization at baseline and after 4 weeks of treatment. One outpatient department visit at week 2.

All patients have to be referred by their physician, who will receive a summary of the results at the end of the patient's study participation.

If patients are randomized to active drug and respond to it with decrease in pruritus, a one week supply of medication is given. The referring physician could prescribe the drug for long term use. If the patient is randomized to placebo they can be treated with active medication provided by the study for 4 weeks, at end of which, the drug could be prescribed by referring physician if the patient responds to the drug with decrease in the pruritus.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Study of Gabapentin for the Pruritus of Cholestasis

Actual Study Start Date :

Nov 1, 2000

Actual Primary Completion Date :

Jan 1, 2004

Actual Study Completion Date :

Jan 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gabapentin	Drug: Gabapentin Under code, the study drug was started at 100 mg by mouth 3 times a day for 3 days, to be increased, if necessary and in the absence of side effects, by 300 mg every 3 days to a maximum of 2,400 mg daily in divided doses.
Placebo Comparator: Placebo	Drug: Placebo

Arm

Intervention/Treatment

Experimental: Gabapentin

Drug: Gabapentin

Under code, the study drug was started at 100 mg by mouth 3 times a day for 3 days, to be increased, if necessary and in the absence of side effects, by 300 mg every 3 days to a maximum of 2,400 mg daily in divided doses.

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Change in scratching activity monitoring system [4 weeks]
A scratching activity monitoring system specifically designed to record scratching behavior independent of gross body movement

Secondary Outcome Measures

Change in visual analogue scale for pruritus [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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