Trial Outcomes & Findings for Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis (NCT NCT00637780)

NCT ID: NCT00637780

Last Updated: 2017-02-23

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Results posted on

2017-02-23

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sulfasalazine in Juvenile Idiopathic Arthritis n=2 Participants 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.
Age, Continuous	15.0 years STANDARD_DEVIATION 1.4 • n=5 Participants
Gender Female	1 Participants n=5 Participants
Gender Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Population: The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.

Outcome measures

Outcome measures
Measure	Sulfasalazine in Juvenile Idiopathic Arthritis n=2 Participants 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.
Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin) Cmax - Value 1	17.6 micrograms (mcg)/milliliter (mL) Interval 4.51 to 17.6
Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin) Cmax - Value 2	4.51 micrograms (mcg)/milliliter (mL) Interval 0.988 to 4.28
Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin) Cmin - Value 1	4.28 micrograms (mcg)/milliliter (mL)
Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin) Cmin - Value 2	0.988 micrograms (mcg)/milliliter (mL)

PRIMARY outcome

Timeframe: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Population: The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.

Outcome measures

Outcome measures
Measure	Sulfasalazine in Juvenile Idiopathic Arthritis n=2 Participants 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.
Sulfasalazine Time for Cmax (Tmax) at Steady State Value 1	2.02 hours (hr)
Sulfasalazine Time for Cmax (Tmax) at Steady State Value 2	5.92 hours (hr)

PRIMARY outcome

Timeframe: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Population: The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.

Outcome measures

Outcome measures
Measure	Sulfasalazine in Juvenile Idiopathic Arthritis n=2 Participants 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.
Sulfasalazine Area Under the Concentration-time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) at Steady State Value 1	110 mcg*hr/mL
Sulfasalazine Area Under the Concentration-time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) at Steady State Value 2	34.7 mcg*hr/mL

PRIMARY outcome

Timeframe: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Population: The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.

Sulfapyridine and 5-aminosalicylic acid (5-ASA) are primary metabolites of sulfasalazine, the study drug.

Outcome measures

Outcome measures
Measure	Sulfasalazine in Juvenile Idiopathic Arthritis n=2 Participants 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.
Sulfapyridine Steady State Cmax and Cmin Cmax - Value 1	21.7 mcg/mL
Sulfapyridine Steady State Cmax and Cmin Cmax - Value 2	7.68 mcg/mL
Sulfapyridine Steady State Cmax and Cmin Cmin - Value 1	14.7 mcg/mL
Sulfapyridine Steady State Cmax and Cmin Cmin - Value 2	4.79 mcg/mL

PRIMARY outcome

Timeframe: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Population: The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.

Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.

Outcome measures

Outcome measures
Measure	Sulfasalazine in Juvenile Idiopathic Arthritis n=2 Participants 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.
Sulfapyridine Tmax at Steady State Value 1	4.00 hr
Sulfapyridine Tmax at Steady State Value 2	11.9 hr

PRIMARY outcome

Timeframe: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Population: The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.

Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.

Outcome measures

Outcome measures
Measure	Sulfasalazine in Juvenile Idiopathic Arthritis n=2 Participants 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.
Sulfapyridine AUCtau at Steady State Value 1	232 mcg*hr/mL
Sulfapyridine AUCtau at Steady State Value 2	67.3 mcg*hr/mL

PRIMARY outcome

Timeframe: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Population: The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.

Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.

Outcome measures

Outcome measures
Measure	Sulfasalazine in Juvenile Idiopathic Arthritis n=2 Participants 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.
5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin Cmax - Value 1	0.208 mcg/mL
5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin Cmax - Value 2	0.0982 mcg/mL
5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin Cmin - Value 1	0.0439 mcg/mL
5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin Cmin - Value 2	0.0816 mcg/mL

PRIMARY outcome

Timeframe: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Population: The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.

Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.

Outcome measures

Outcome measures
Measure	Sulfasalazine in Juvenile Idiopathic Arthritis n=2 Participants 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.
5-aminosalicylic Acid (5-ASA) Tmax at Steady State Value 1	0.000 hr
5-aminosalicylic Acid (5-ASA) Tmax at Steady State Value 2	11.9 hr

PRIMARY outcome

Timeframe: Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose

Population: The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.

Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug.

Outcome measures

Outcome measures
Measure	Sulfasalazine in Juvenile Idiopathic Arthritis n=2 Participants 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.
5-aminosalicylic Acid (5-ASA) AUCtau at Steady State Value 1	1.63 mcg*hr/mL
5-aminosalicylic Acid (5-ASA) AUCtau at Steady State Value 2	1.04 mcg*hr/mL

SECONDARY outcome

Timeframe: Screening through to and including 28 calendar days after the last administration of the investigational product

Population: The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.

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.

Outcome measures

Outcome measures
Measure	Sulfasalazine in Juvenile Idiopathic Arthritis n=2 Participants 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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs TEAEs	0 participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs SAEs	0 participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs Withdrawals due to TEAEs	0 participants

SECONDARY outcome

Timeframe: Screening, Day 0, and Day 7

Population: The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.

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).

Outcome measures

Outcome measures
Measure	Sulfasalazine in Juvenile Idiopathic Arthritis n=2 Participants 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.
Number of Participants With Laboratory Test Abnormalities	1 participants

SECONDARY outcome

Timeframe: Screening, Day 0, and Day 7

Population: The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses.

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.

Outcome measures

Outcome measures
Measure	Sulfasalazine in Juvenile Idiopathic Arthritis n=2 Participants 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.
Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria	0 participants

Adverse Events

Sulfasalazine in Juvenile Idiopathic Arthritis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc

Phone: 18007181021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER