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Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arthritis, Juvenile Rheumatoid

Intervention: Sulfasalazine (Drug)

Phase: Phase 4

Status: Suspended

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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 who have been continuously treated with generic sulfasalazine delayed release formulation and have tolerated the product for at least 3 months prior to study enrolment and who are switched to Azulfidine-EN at least 8 days prior to Day 0 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 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:

- Patient currently with systemic features 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

Private Office, Guadalajara, Jalisco 44650, Mexico

University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: June 2010
Last updated: April 8, 2015

Page last updated: August 23, 2015

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