Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis
Information source: Pfizer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arthritis, Juvenile Rheumatoid
Intervention: Sulfasalazine (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
This study will characterize the steady state pharmacokinetics of sulfasalazine delayed
release tablets in pediatric Juvenile Idiopathic Arthritis patients. Data from this study
will fulfill the post approval commitment to the FDA.
Clinical Details
Official title: An Open Label Non-Randomized Study To Characterize The Steady State Pharmacokinetics Of Sulfasalazine Delayed Release Tablets In Children With Juvenile Idiopathic Arthritis
Study design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Primary outcome: Pharmacokinetic endpoints to include:sulfasalazine, sulfapyridine and 5-aminosalicylic acid: steady state (Day 7): Cmax ss, Tmax ss, AUCtau , Cmin ss, t1/2(data permitting)
Secondary outcome: Safety endpoints to include adverse events, safety laboratory tests, and vital signs.
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with a diagnosis of oligoarticular, polyarticular, psoriatic or
enthesitis-related JIA as determined by ILAR criteria. Patients with a history of
systemic onset JIA whose disease has progressed to polyarthritis or oligoarthritis
without current systemic features and who have been continuously treated with
sulfasalazine (Azulfidine-EN) and have tolerated the product for at least 3 months
prior to study enrolment are eligible.
- 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 16 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:
- Patient with a history of or currently in the active phase of systemic JIA.
- 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
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021 Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2008
Ending date: May 2009
Last updated: October 27, 2008
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