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Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00637780 |
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.
Condition | Intervention | Phase |
---|---|---|
Arthritis, Juvenile Rheumatoid |
Drug: Sulfasalazine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
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 |
Estimated Enrollment: | 12 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 6 days
|
Drug: 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
|
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion 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.
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
United States, New York | |
Pfizer Investigational Site | Recruiting |
New York, New York, United States, 10032 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A0031005 |
Study First Received: | March 11, 2008 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00637780 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Sulfasalazine delayed release tablets, azulfidine entabs, Pharmacokinetics, Juvenile Idiopathic Arthritis (JIA) |
Anti-Inflammatory Agents Arthritis, Juvenile Rheumatoid Autoimmune Diseases Joint Diseases Sulfasalazine Arthritis, Rheumatoid Rheumatic Diseases Musculoskeletal Diseases |
Analgesics, Non-Narcotic Arthritis Connective Tissue Diseases Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Anti-Inflammatory Agents Anti-Infective Agents Arthritis, Juvenile Rheumatoid Autoimmune Diseases Immune System Diseases Joint Diseases Sulfasalazine Physiological Effects of Drugs Gastrointestinal Agents Arthritis, Rheumatoid Rheumatic Diseases Pharmacologic Actions |
Musculoskeletal Diseases Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Arthritis Connective Tissue Diseases Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |