Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis
NCT ID: NCT00637780
Last Updated: 2017-02-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
2 participants
INTERVENTIONAL
2010-06-30
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 6 days
Sulfasalazine
Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 7 days. Blood sampling for Pharmacokinetic assessment to be performed on Day 7
Interventions
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Sulfasalazine
Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 7 days. Blood sampling for Pharmacokinetic assessment to be performed on Day 7
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be at least 6 years of age and has not reached his/her 18th birthday prior to the Baseline Visit (Day 0).
* Onset of JIA must have occurred prior to the patient's 16th birthday.
* Patients must weigh at least 20 kg.
* Patients must be on sulfasalazine 500 mg delayed release tablets and the total daily dose must be within the specified range of 30-60 mg/kg/day with a maximum daily dose of 3 g/day
Exclusion Criteria
* Hypersensitivity to sulfasalazine , its metabolites, sulfonamides or salicylates.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
* Inability to swallow whole (uncrushed) sulfasalazine 500 mg delayed release tablets as required by protocol
6 Years
17 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University Hospitals Case Medical Center
Cleveland, Ohio, United States
Private Office
Guadalajara, Jalisco, Mexico
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0031005
Identifier Type: -
Identifier Source: org_study_id
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