Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00004357 |
Date of registration:
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18/10/1999 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Absorption of Corticosteroids in Children With Juvenile Dermatomyositis
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Scientific title:
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Phase II Study of Prednisolone/Methylprednisolone Absorption in Children With Juvenile Dermatomyositis |
Date of first enrolment:
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September 1997 |
Target sample size:
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6 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00004357 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Lauren M. Pachman, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Feinberg School of Medicine, Northwestern University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Juvenile dermatomyositis with evidence of active vasculitis
- Elevated von Willebrand factor antigen prior to study entry
- Elevated neopterin level prior to study entry
Exclusion Criteria:
- Severe renal involvement
- Critically ill or clinically unstable
- Diseases other than dermatomyositis with vasculitis
Age minimum:
4 Years
Age maximum:
21 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Vasculitis, Hypersensitivity
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Connective Tissue Diseases
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Dermatomyositis
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Vasculitis
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Intervention(s)
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Drug: Prednisolone
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Drug: Methylprednisolone
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Secondary ID(s)
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NU-465
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199/11924
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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