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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
Enrollment 2
Recruitment Details 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  
Arm/Group Title Sulfasalazine in Juvenile Idiopathic Arthritis
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Sulfasalazine in Juvenile Idiopathic Arthritis
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
The only 2 participants who were enrolled and completed the study at study termination were included in all analyses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants
15.0  (1.4)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
1.Primary Outcome
Title Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin)
Hide Description [Not Specified]
Time Frame Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.
Arm/Group Title Sulfasalazine in Juvenile Idiopathic Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: micrograms (mcg)/milliliter (mL)
Cmax - Value 1 17.6
Cmax - Value 2 4.51
Cmin - Value 1 4.28
Cmin - Value 2 0.988
2.Primary Outcome
Title Sulfasalazine Time for Cmax (Tmax) at Steady State
Hide Description [Not Specified]
Time Frame Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.
Arm/Group Title Sulfasalazine in Juvenile Idiopathic Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: hours (hr)
Value 1 2.02
Value 2 5.92
3.Primary Outcome
Title Sulfasalazine Area Under the Concentration-time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) at Steady State
Hide Description [Not Specified]
Time Frame Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.
Arm/Group Title Sulfasalazine in Juvenile Idiopathic Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: mcg*hr/mL
Value 1 110
Value 2 34.7
4.Primary Outcome
Title Sulfapyridine Steady State Cmax and Cmin
Hide Description Sulfapyridine and 5-aminosalicylic acid (5-ASA) are primary metabolites of sulfasalazine, the study drug.
Time Frame Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.
Arm/Group Title Sulfasalazine in Juvenile Idiopathic Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: mcg/mL
Cmax - Value 1 21.7
Cmax - Value 2 7.68
Cmin - Value 1 14.7
Cmin - Value 2 4.79
5.Primary Outcome
Title Sulfapyridine Tmax at Steady State
Hide Description Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Time Frame Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.
Arm/Group Title Sulfasalazine in Juvenile Idiopathic Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: hr
Value 1 4.00
Value 2 11.9
6.Primary Outcome
Title Sulfapyridine AUCtau at Steady State
Hide Description Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Time Frame Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.
Arm/Group Title Sulfasalazine in Juvenile Idiopathic Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: mcg*hr/mL
Value 1 232
Value 2 67.3
7.Primary Outcome
Title 5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin
Hide Description Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Time Frame Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.
Arm/Group Title Sulfasalazine in Juvenile Idiopathic Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: mcg/mL
Cmax - Value 1 0.208
Cmax - Value 2 0.0982
Cmin - Value 1 0.0439
Cmin - Value 2 0.0816
8.Primary Outcome
Title 5-aminosalicylic Acid (5-ASA) Tmax at Steady State
Hide Description Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Time Frame Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.
Arm/Group Title Sulfasalazine in Juvenile Idiopathic Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: hr
Value 1 0.000
Value 2 11.9
9.Primary Outcome
Title 5-aminosalicylic Acid (5-ASA) AUCtau at Steady State
Hide Description Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.
Time Frame Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.
Arm/Group Title Sulfasalazine in Juvenile Idiopathic Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: mcg*hr/mL
Value 1 1.63
Value 2 1.04
10.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs
Hide Description 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.
Time Frame Screening through to and including 28 calendar days after the last administration of the investigational product
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.
Arm/Group Title Sulfasalazine in Juvenile Idiopathic Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
TEAEs 0
SAEs 0
Withdrawals due to TEAEs 0
11.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities
Hide Description 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).
Time Frame Screening, Day 0, and Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.
Arm/Group Title Sulfasalazine in Juvenile Idiopathic Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
1
12.Secondary Outcome
Title Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria
Hide Description 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.
Time Frame Screening, Day 0, and Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.
Arm/Group Title Sulfasalazine in Juvenile Idiopathic Arthritis
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
0
Time Frame Screening through to and including 28 calendar days after the last administration of the investigational product.
Adverse Event Reporting Description All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Sulfasalazine in Juvenile Idiopathic Arthritis
Hide Arm/Group Description 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.
All-Cause Mortality
Sulfasalazine in Juvenile Idiopathic Arthritis
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sulfasalazine in Juvenile Idiopathic Arthritis
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sulfasalazine in Juvenile Idiopathic Arthritis
Affected / at Risk (%)
Total   0/2 (0.00%) 
The study was terminated prematurely and only 2 participants were enrolled and completed the study.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc
Phone: 18007181021
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