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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00637780
First received: March 11, 2008
Last updated: August 12, 2014
Last verified: August 2014
  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 1

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:


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: September 2014
Estimated Primary Completion Date: September 2014 (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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
Mexico
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44650
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00637780     History of Changes
Other Study ID Numbers: A0031005
Study First Received: March 11, 2008
Last Updated: August 12, 2014
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
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Sulfasalazine
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014