Clinical trial NCT00058890: Gabapentin to Treat Itch in Patients With Liver Disease
Official title: Study of Gabapentin for the Pruritus of Cholestasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Disease
Cholestasis
Cirrhosis
Pruritus
Itching
Keywords: itching
pruritus
cholestasis
liver disease
hepatitis
cirrhosis
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-04-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in scratching activity monitoring system
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in visual analogue scale for pruritus
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University College of Physicians and Surgeons
state: New York
Study officials:
affiliation: New York Presbyterian Hospital Columbia University College of Physicians and Surgeons
name: Nora V Bergasa, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1002/hep.21370.