Gabapentin to Treat Itch in Patients With Liver Disease
|ClinicalTrials.gov Identifier: NCT00058890|
Recruitment Status : Completed
First Posted : April 16, 2003
Last Update Posted : October 13, 2017
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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Study of Gabapentin for the Pruritus of Cholestasis|
|Actual Study Start Date :||November 2000|
|Actual Primary Completion Date :||January 2004|
|Actual Study Completion Date :||January 2004|
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|
- 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
- Change in visual analogue scale for pruritus [ Time Frame: 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00058890
|United States, New York|
|Columbia University College of Physicians and Surgeons|
|New York, New York, United States, 10032|
|Principal Investigator:||Nora V Bergasa, M.D.||New York Presbyterian Hospital Columbia University College of Physicians and Surgeons|