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: May 6, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 11, 2008

Last Updated Date

May 6, 2013

Start Date ^ICMJE

June 2010

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Pharmacokinetic endpoints to include:sulfasalazine, sulfapyridine and 5-aminosalicylic acid: steady state (Day 7): Cmax ss, Tmax ss, AUCtau (extrapolated), Cmin ss, t1/2 [ Time Frame: Day 7 to Day 9 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00637780 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open Label Non-Randomized Study To Characterize The Steady State Pharmacokinetics Of Sulfasalazine Delayed Release Tablets In Children With Juvenile Idiopathic Arthritis

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Arthritis, Juvenile Rheumatoid

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1

Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 6 days

Intervention: Drug: Sulfasalazine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2013

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00637780

Other Study ID Numbers ^ICMJE

A0031005

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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