Gabapentin to Treat Itch in Patients With Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00058890
Recruitment Status : Completed
First Posted : April 16, 2003
Last Update Posted : October 13, 2017
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

April 14, 2003
April 16, 2003
October 13, 2017
November 2000
January 2004   (Final data collection date for primary outcome measure)
Change in scratching activity monitoring system [ Time Frame: 4 weeks ]
A scratching activity monitoring system specifically designed to record scratching behavior independent of gross body movement
Not Provided
Complete list of historical versions of study NCT00058890 on Archive Site
Change in visual analogue scale for pruritus [ Time Frame: 4 weeks ]
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Not Provided
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Gabapentin to Treat Itch in Patients With Liver Disease
Study of Gabapentin for the Pruritus of Cholestasis

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.

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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Liver Disease
  • Cholestasis
  • Cirrhosis
  • Pruritus
  • Itching
  • 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.
  • Drug: Placebo
  • Experimental: Gabapentin
    Intervention: Drug: Gabapentin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2004
January 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R03 --9618 (completed 2005)
R03DK055618 ( U.S. NIH Grant/Contract )
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Principal Investigator: Nora V Bergasa, M.D. New York Presbyterian Hospital Columbia University College of Physicians and Surgeons
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP