Gabapentin to Treat Itch in Patients With Liver Disease
|First Received Date ICMJE||April 14, 2003|
|Last Updated Date||March 17, 2010|
|Start Date ICMJE||November 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Change in scratching activity monitoring system|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00058890 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Change in visual analogue scale for pruritus|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Gabapentin to Treat Itch in Patients With Liver Disease|
|Official Title ICMJE||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.
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 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 Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Intervention ICMJE||Drug: gabapentin|
|Study Arm (s)||Not Provided|
|Publications *||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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||January 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Inclusion criteria include:
Patients must have:
Exclusion criteria include:
|Ages||18 Years to 80 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00058890|
|Other Study ID Numbers ICMJE||R03 --9618 (completed 2005)|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Verification Date||March 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP