Trials / Terminated
TerminatedNCT00637780
Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis
An Open Label Non-randomized Study To Characterize The Steady State Pharmacokinetics Of Sulfasalazine Delayed Release Tablets In Children With Juvenile Idiopathic Arthritis
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2014-01-01
- Completion
- 2014-01-01
- First posted
- 2008-03-18
- Last updated
- 2017-02-23
- Results posted
- 2017-02-23
Locations
2 sites across 2 countries: United States, Mexico
Source: ClinicalTrials.gov record NCT00637780. Inclusion in this directory is not an endorsement.