Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | April 14, 2003 | ||||
Last Updated Date | December 1, 2006 | ||||
Start Date ICMJE | November 2000 | ||||
Current Primary Outcome Measures ICMJE |
Change in scratching activity monitoring system | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
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 | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Gabapentin to Treat Itch in Patients With Liver Disease | ||||
Official Title ICMJE | Study 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 Phase | Phase III | ||||
Study Type ICMJE | Interventional | ||||
Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study | ||||
Condition ICMJE |
|
||||
Intervention ICMJE | Drug: gabapentin | ||||
Study Arms / Comparison Groups | |||||
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 National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 30 | ||||
Completion Date | January 2004 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion criteria include:
Patients must have:
Exclusion criteria include:
|
||||
Gender | Both | ||||
Ages | 18 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00058890 | ||||
Responsible Party | |||||
Study ID Numbers ICMJE | 9618 | ||||
Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
|
||||
Information Provided By | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
Verification Date | July 2006 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |