Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004357
Status:
COMPLETED
Last Update Posted:
2011-07-22
First Post:
1999-10-18
Brief Title:
Absorption of Corticosteroids in Children With Juvenile Dermatomyositis
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase II Study of PrednisoloneMethylprednisolone Absorption in Children With Juvenile Dermatomyositis
Status:
COMPLETED
Status Verified Date:
2011-07
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:
Juvenile dermatomyositis JDM is a connective tissue disease that causes skin rash and weak muscles in children The purpose of this study is to measure the absorption of oral prednisolone and intravenous IV methylprednisolone and to determine levels of disease activity indicators in the blood These levels will be compared to see if there are patterns specific to active and less active JDM
Detailed Description:
JDM is a connective tissue disease that is characterized by inflammation of the muscles and the skin Corticosteroids such as prednisolone and methylprednisolone can be administered to help control symptoms of the disease but absorption patterns of these medications in oral and IV forms are unknown This study will assess absorption of oral prednisolone and IV methylprednisolone measure levels of two disease activity indicators von Willebrand factor and neopterin and correlate these values in children with JDM
Patients will participate in this study twice within a period of up to a year once when the patients disease is active and again 6 to 12 months later when the disease is less active Each of the two study periods will last two nights and two days Patients will be admitted to the hospital the first night and a small IV port will be inserted in the patients arm the first morning to allow for multiple blood draws without additional needle sticks Patients will receive oral prednisolone the first morning and IV methylprednisolone the second morning Baseline blood draws will be performed prior to administration of drug with 13 additional draws over a 6 hour period following drug administration Following the final blood draw on the second day the IV port will be removed from the patients arm and the patient will be discharged from the hospital
Blood drawn from patients will be assessed for absorption of the drugs and levels of von Willebrand factor and neopterin Patients will undergo the same sequence of events sometime between 6 to 12 months after the first hospitalization after their vasculitis is judged to be less active
Patients will participate in this study twice within a period of up to a year once when the patients disease is active and again 6 to 12 months later when the disease is less active Each of the two study periods will last two nights and two days Patients will be admitted to the hospital the first night and a small IV port will be inserted in the patients arm the first morning to allow for multiple blood draws without additional needle sticks Patients will receive oral prednisolone the first morning and IV methylprednisolone the second morning Baseline blood draws will be performed prior to administration of drug with 13 additional draws over a 6 hour period following drug administration Following the final blood draw on the second day the IV port will be removed from the patients arm and the patient will be discharged from the hospital
Blood drawn from patients will be assessed for absorption of the drugs and levels of von Willebrand factor and neopterin Patients will undergo the same sequence of events sometime between 6 to 12 months after the first hospitalization after their vasculitis is judged to be less active
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| NU-465 | None | None | None |