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| Descriptive Information Fields | |||||||||
| Brief Title † | Absorption of Corticosteroids in Children With Juvenile Dermatomyositis | ||||||||
| Official Title † | Phase II Study of Prednisolone/Methylprednisolone Absorption in Children With Juvenile Dermatomyositis | ||||||||
| 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. |
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| 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 patient's 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 patient's 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 patient's 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. |
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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Vasculitis, Hypersensitivity Connective Tissue Diseases Dermatomyositis Vasculitis |
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| Intervention † | Drug: Methylprednisolone Drug: Prednisolone |
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| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 24 | ||||||||
| Start Date † | September 1997 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 4 Years to 21 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00004357 | ||||||||
| Organization ID | 199/11924 | ||||||||
| Secondary IDs †† | NU-465 | ||||||||
| Study Sponsor † | Northwestern University | ||||||||
| Collaborators †† | Children's Memorial Hospital | ||||||||
| Investigators † |
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| Information Provided By | Northwestern University | ||||||||
| Verification Date | May 2004 | ||||||||
| First Received Date † | October 18, 1999 | ||||||||
| Last Updated Date | May 9, 2006 | ||||||||
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