Gabapentin to Treat Itch in Patients With Liver Disease

Overview[ - collapse ][ - ]

Purpose 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. 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.
ConditionLiver Disease
Cholestasis
Cirrhosis
Pruritus
Itching
InterventionDrug: gabapentin
PhasePhase 3
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible PartyNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov IdentifierNCT00058890
First ReceivedApril 14, 2003
Last UpdatedMarch 17, 2010
Last verifiedMarch 2010

Tracking Information[ + expand ][ + ]

First Received DateApril 14, 2003
Last Updated DateMarch 17, 2010
Start DateNovember 2000
Estimated Primary Completion DateJanuary 2004
Current Primary Outcome MeasuresChange in scratching activity monitoring system
Current Secondary Outcome MeasuresChange in visual analogue scale for pruritus

Descriptive Information[ + expand ][ + ]

Brief TitleGabapentin to Treat Itch in Patients With Liver Disease
Official TitleStudy of Gabapentin for the Pruritus of Cholestasis
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.

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
OPD 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 TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Condition
  • Liver Disease
  • Cholestasis
  • Cirrhosis
  • Pruritus
  • Itching
InterventionDrug: gabapentin
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment30
Estimated Completion DateJanuary 2004
Estimated Primary Completion DateNot Provided
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00058890
Other Study ID NumbersR03 --9618 (completed 2005)
Has Data Monitoring CommitteeNot Provided
Information Provided ByNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorsNot Provided
Investigators Principal Investigator: Nora V Bergasa, M.D. New York Presbyterian Hospital Columbia University College of Physicians and Surgeons
Verification DateMarch 2010

Locations[ + expand ][ + ]

Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032