Gabapentin to Treat Itch in Patients With Liver Disease
Condition: Liver Disease; Cholestasis; Cirrhosis; Pruritus; Itching
MeSH terms: Liver Diseases; Cholestasis; Pruritus; Fibrosis
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Gabapentin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: itching; pruritus; cholestasis; liver disease; hepatitis; cirrhosis