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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:
Sponsor: Pfizer

Current Primary Outcome:

  • 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&

    Original Primary Outcome: 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 ]

    Current Secondary Outcome:

    • 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: Safety endpoints to include adverse events, safety laboratory tests, and vital signs. [ Time Frame: Day 1 through Day 9 ]

    Information By: Pfizer

    Dates:
    Date Received: March 11, 2008
    Date Started: June 2010
    Date Completion:
    Last Updated: January 3, 2017
    Last Verified: January 2017