Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058890
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2003-04-14
Brief Title:
Gabapentin to Treat Itch in Patients With Liver Disease
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Study of Gabapentin for the Pruritus of Cholestasis
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 patients 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
All patients have to be referred by their physician who will receive a summary of the results at the end of the patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R03DK055618 | NIH | None | httpsreporternihgovquickSearchR03DK055618 |