Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00637780

Purpose

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

Resource links provided by NLM:

Genetics Home Reference related topics: juvenile idiopathic arthritis

MedlinePlus related topics: Juvenile Rheumatoid Arthritis

Drug Information available for: Sulfasalazine

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety endpoints to include adverse events, safety laboratory tests, and vital signs. [ Time Frame: Day 1 through Day 9 ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	June 2010
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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 Other Name: AZULFIDINE EN-tabs Tablets

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637780

Locations

United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier:	NCT00637780 History of Changes
Other Study ID Numbers:	A0031005
Study First Received:	March 11, 2008
Last Updated:	February 8, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Sulfasalazine delayed release tablets
azulfidine entabs
Pharmacokinetics
Juvenile Idiopathic Arthritis (JIA)

Additional relevant MeSH terms:

Arthritis
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Sulfasalazine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Anti-Infective Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012