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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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Arthritis, Juvenile Rheumatoid
Intervention: Drug: Sulfasalazine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The last participant enrolled in 2014 but the study was kept open for another 2 years and enrollment was not stopped. However, by 2016, no additional participants were enrolled and thus the study was closed. As such, the basic results for this study are only prepared in 2016 though last participant's last visit was in 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sulfasalazine in Juvenile Idiopathic Arthritis All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.

Participant Flow:   Overall Study
    Sulfasalazine in Juvenile Idiopathic Arthritis
STARTED   2 
COMPLETED   2 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The only 2 participants who were enrolled and completed the study at study termination were included in all analyses.

Reporting Groups
  Description
Sulfasalazine in Juvenile Idiopathic Arthritis All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.

Baseline Measures
   Sulfasalazine in Juvenile Idiopathic Arthritis 
Overall Participants Analyzed 
[Units: Participants]
 2 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.0  (1.4) 
Gender 
[Units: Participants]
Count of Participants
 
Female      1  50.0% 
Male      1  50.0% 


  Outcome Measures

1.  Primary:   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 ]

2.  Primary:   Sulfasalazine Time for Cmax (Tmax) at Steady State   [ Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose ]

3.  Primary:   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 ]

4.  Primary:   Sulfapyridine Steady State Cmax and Cmin   [ Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose ]

5.  Primary:   Sulfapyridine Tmax at Steady State   [ Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose ]

6.  Primary:   Sulfapyridine AUCtau at Steady State   [ Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose ]

7.  Primary:   5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin   [ Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose ]

8.  Primary:   5-aminosalicylic Acid (5-ASA) Tmax at Steady State   [ Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose ]

9.  Primary:   5-aminosalicylic Acid (5-ASA) AUCtau at Steady State   [ Time Frame: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose ]

10.  Secondary:   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 ]

11.  Secondary:   Number of Participants With Laboratory Test Abnormalities   [ Time Frame: Screening, Day 0, and Day 7 ]

12.  Secondary:   Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria   [ Time Frame: Screening, Day 0, and Day 7 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated prematurely and only 2 participants were enrolled and completed the study.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc
phone: 18007181021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00637780     History of Changes
Other Study ID Numbers: A0031005
First Submitted: March 11, 2008
First Posted: March 18, 2008
Results First Submitted: September 20, 2016
Results First Posted: February 23, 2017
Last Update Posted: February 23, 2017