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

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ClinicalTrials.gov Identifier: NCT00637780
Recruitment Status : Terminated (Study terminated on 13 April 2016 for business reasons. No safety and/or efficacy concerns contributed to the termination of the study)
First Posted : March 18, 2008
Results First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 11, 2008
First Posted Date  ICMJE March 18, 2008
Results First Submitted Date  ICMJE September 20, 2016
Results First Posted Date  ICMJE February 23, 2017
Last Update Posted Date February 23, 2017
Study Start Date  ICMJE June 2010
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
  • Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin) [ Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose ]
  • Sulfasalazine Time for Cmax (Tmax) at Steady State [ Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose ]
  • Sulfasalazine Area Under the Concentration-time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) at Steady State [ Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose ]
  • Sulfapyridine Steady State Cmax and Cmin [ Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose ]
    Sulfapyridine and 5-aminosalicylic acid (5-ASA) are primary metabolites of sulfasalazine, the study drug.
  • Sulfapyridine Tmax at Steady State [ Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose ]
    Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
  • Sulfapyridine AUCtau at Steady State [ Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose ]
    Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
  • 5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin [ Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose ]
    Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
  • 5-aminosalicylic Acid (5-ASA) Tmax at Steady State [ Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose ]
    Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
  • 5-aminosalicylic Acid (5-ASA) AUCtau at Steady State [ Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose ]
    Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
  • Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs [ Time Frame: Screening through to and including 28 calendar days after the last administration of the investigational product ]
    An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
  • Number of Participants With Laboratory Test Abnormalities [ Time Frame: Screening, Day 0, and Day 7 ]
    Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes,clinical chemistry, and urinalysis (dipstick and microscopy).
  • Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria [ Time Frame: Screening, Day 0, and Day 7 ]
    Vital sign values which met categorical summarization criteria included: supine/sitting pulse rate less than (<) 40 or more than (>) 120 beats per minute (bpm); erect pulse rate <40 or >140 bpm; changes from baseline in same posture of systolic blood pressure (SBP) more than or equal to (>=) 30 millimeters of mercury (mm Hg) or diastolic blood pressure (DBP) >=20 mm Hg; SBP <90 mm Hg; and DBP <50 mm Hg.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2008)
Safety endpoints to include adverse events, safety laboratory tests, and vital signs. [ Time Frame: Day 1 through Day 9 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE 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 Terminated
Actual Enrollment  ICMJE
 (submitted: April 27, 2016)
2
Original Estimated Enrollment  ICMJE
 (submitted: March 11, 2008)
12
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico,   United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00637780
Other Study ID Numbers  ICMJE A0031005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2017

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