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Study terminated on 13 April 2016 for business reasons. No safety and/or efficacy concerns contributed to the termination of the study
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Sulfasalazine delayed release tablets 30-60 mg/kg/day (divided into BID doses) for 6 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulfasalazine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin) | Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose | |
| Sulfasalazine Time for Cmax (Tmax) at Steady State | 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 | Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose | |
| Sulfapyridine Steady State Cmax and Cmin | Sulfapyridine and 5-aminosalicylic acid (5-ASA) are primary metabolites of sulfasalazine, the study drug. | Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose |
| Sulfapyridine Tmax at Steady State | Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug. | Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose |
| Sulfapyridine AUCtau at Steady State | Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug. | Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose |
| 5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin | Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug. | Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose |
| 5-aminosalicylic Acid (5-ASA) Tmax at Steady State |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States | ||
| Private Office |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The only 2 participants who were enrolled and completed the study at study termination were included in all analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sulfasalazine Steady State Maximum Plasma Concentration (Cmax) and Predose Concentration (Cmin) | The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses. | Posted | Number | micrograms (mcg)/milliliter (mL) | Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose |
|
|
Screening through to and including 28 calendar days after the last administration of the investigational product.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The study was terminated prematurely and only 2 participants were enrolled and completed the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc | 18007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D012460 | Sulfasalazine |
| D013411 | Sulfadiazine |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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|
Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug. |
| Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose |
| 5-aminosalicylic Acid (5-ASA) AUCtau at Steady State | Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug. | Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose |
| Screening through to and including 28 calendar days after the last administration of the investigational product |
| Number of Participants With Laboratory Test Abnormalities | 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). | Screening, Day 0, and Day 7 |
| Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria | 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. | Screening, Day 0, and Day 7 |
| Guadalajara |
| Jalisco |
| 44650 |
| Mexico |
| years |
|
| Gender | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Sulfasalazine Time for Cmax (Tmax) at Steady State | The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses. | Posted | Number | hours (hr) | Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose |
|
|
|
| Primary | Sulfasalazine Area Under the Concentration-time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) at Steady State | The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses. | Posted | Number | mcg*hr/mL | Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose |
|
|
|
| Primary | Sulfapyridine Steady State Cmax and Cmin | Sulfapyridine and 5-aminosalicylic acid (5-ASA) are primary metabolites of sulfasalazine, the study drug. | The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses. | Posted | Number | mcg/mL | Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose |
|
|
|
| Primary | Sulfapyridine Tmax at Steady State | Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug. | The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses. | Posted | Number | hr | Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose |
|
|
|
| Primary | Sulfapyridine AUCtau at Steady State | Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug. | The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses. | Posted | Number | mcg*hr/mL | Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose |
|
|
|
| Primary | 5-aminosalicylic Acid (5-ASA) Steady State Cmax and Cmin | Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug. | The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses. | Posted | Number | mcg/mL | Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose |
|
|
|
| Primary | 5-aminosalicylic Acid (5-ASA) Tmax at Steady State | Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug. | The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses. | Posted | Number | hr | Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose |
|
|
|
| Primary | 5-aminosalicylic Acid (5-ASA) AUCtau at Steady State | Sulfapyridine and 5-ASA are primary metabolites of sulfasalazine, the study drug. | The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses. | Posted | Number | mcg*hr/mL | Day 7 predose, and 2, 4, 6, 10, and 12 hours postdose |
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs | 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. | The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses. | Posted | Number | participants | Screening through to and including 28 calendar days after the last administration of the investigational product |
|
|
|
| Secondary | Number of Participants With Laboratory Test Abnormalities | 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). | The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses. | Posted | Number | participants | Screening, Day 0, and Day 7 |
|
|
|
| Secondary | Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria | 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. | The 2 participants who were enrolled and completed the study at the time of study termination were included in all analyses. | Posted | Number | participants | Screening, Day 0, and Day 7 |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Sulfur Compounds |
| D000096926 | Benzenesulfonamides |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Title | Measurements |
|---|---|
|
| Cmin - Value 2 |
|
| Title | Measurements |
|---|---|
|
| Cmin - Value 2 |
|
| Title | Measurements |
|---|---|
|