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As part of the Pediatric Research Equity Act (PREA) commitment, the objectives of the study are to characterize the pharmacokinetic (PK) profile and to determine the safety and tolerability of diclofenac potassium oral solution in pediatric subjects experiencing mild to moderate acute pain.
This is an open-label study with pediatric subjects, ages 2-12 years, who will be dosed with diclofenac potassium oral solution, based on weight, every 6 hours as needed for the treatment of mild to moderate acute pain for up to 4 days. PK samples will be collected through 6 hours after the first dose. Safety data will be collected throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| diclofenac potassium oral solution | Experimental | 5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diclofenac potassium oral solution | Drug | Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8). | • Cmax: maximum concentration (ng/mL) | 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) |
| To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 8). | • Tmax: time to maximum concentration (hr) | 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) |
| To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 8). | • λz: elimination rate constant (1/hr) | 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) |
| To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 8). | • t1/2: terminal elimination half-life (hr) | 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) |
| To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5 of 8). | • AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (hr*ng/mL) |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 7). | • Treatment emergent AEs (TEAEs) | 4 weeks (first dose of study drug and up to 30 days after the date of the last dose of study drug) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 7). |
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Inclusion Criteria:
Other inclusions apply.
Exclusion Criteria:
Other exclusions apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheffield | Alabama | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Diclofenac Potassium Oral Solution | 5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days. diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diclofenac Potassium Oral Solution | 5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days. diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain. |
| 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 | To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8). | • Cmax: maximum concentration (ng/mL) | The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing. | Posted | Mean | Standard Deviation | ng/mL | 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) |
|
4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)
The Safety population included all subjects who have received at least 1 dose of study drug.
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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 | Diclofenac Potassium Oral Solution | 5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days. diclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound Secretion | Injury, poisoning and procedural complications |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Depomed | 510-744-8000 | clinicaltrials@depomed.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059787 | Acute Pain |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) |
| To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6 of 8). | • AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (hr*ng/mL) | 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) |
| To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 8). | • CL/F: apparent clearance (mL/hr). | 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) |
| To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (8 of 8). | • Vz/F: apparent volume of distribution (mL). | 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) |
• Serious adverse events (SAEs) |
| 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 7). | • Withdrawals due to AEs | 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 7). | • Deaths | 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.1 of 7). | • Changes in vital sign measurements: Temperature (degrees C). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.2 of 7). | • Changes in vital sign measurements: Pulse Rate (beats/min). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.3 of 7). | • Changes in vital sign measurements: Respiratory Rate (breaths/min). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.4 of 7). | • Changes in vital sign measurements: Systolic Blood Pressure (mmHg). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.5 of 7). | • Changes in vital sign measurements: Diastolic Blood Pressure (mmHg). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.1 of 7). | • Changes in clinical laboratory results: Hematology - Hematocrit (L/L). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.2 of 7). | • Changes in clinical laboratory results: Hematology - Hemoglobin (g/L). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.3 of 7). | • Changes in clinical laboratory results: Hematology - Platelet Count (10^9/L). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.4 of 7). | • Changes in clinical laboratory results: Hematology - White Blood Cells (10^9/L). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.5 of 7). | • Changes in clinical laboratory results: Hematology - Basophils (%). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.6 of 7). | • Changes in clinical laboratory results: Hematology - Eosinophils (%). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.7 of 7). | • Changes in clinical laboratory results: Hematology - Neutrophils (%). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.8 of 7). | • Changes in clinical laboratory results: Hematology - Lymphocytes (%). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.9 of 7). | • Changes in clinical laboratory results: Hematology - Monocytes (%). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.10 of 7). | • Changes in clinical laboratory results: Chemistry - Albumin (g/L). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.11 of 7). | • Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.12 of 7). | • Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.13 of 7). | • Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.14 of 7). | • Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.15 of 7). | • Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.16 of 7). | • Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.17 of 7). | • Changes in clinical laboratory results: Chemistry - Chloride (mmol/L). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.18 of 7). | • Changes in clinical laboratory results: Chemistry - Creatinine (umol/L). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.19 of 7). | • Changes in clinical laboratory results: Chemistry - Glucose (mmol/L). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.20 of 7). | • Changes in clinical laboratory results: Chemistry - LDH (U/L). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.21 of 7). | • Changes in clinical laboratory results: Chemistry - Potassium (mmol/L). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.22 of 7). | • Changes in clinical laboratory results: Chemistry - Sodium (mmol/L). | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.23 of 7). | • Changes in clinical laboratory results: Urinalysis - pH. | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.24 of 7). | • Changes in clinical laboratory results: Urinalysis - Specific Gravity. | 4 weeks (signed informed consent/assent to the final visit) |
| To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 7). | • Physical examination findings including abnormal clinically significant findings | 4 weeks (signed informed consent/assent to the final visit) |
| Stanford |
| California |
| United States |
| City of Saint Peters | Missouri | United States |
| Dallas | Texas | United States |
| Milwaukee | Wisconsin | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 8). | • Tmax: time to maximum concentration (hr) | The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing. | Posted | Median | Full Range | hr | 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) |
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| Primary | To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 8). | • λz: elimination rate constant (1/hr) | The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing. | Posted | Mean | Standard Deviation | 1/hr | 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) |
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| Primary | To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 8). | • t1/2: terminal elimination half-life (hr) | The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing. | Posted | Mean | Standard Deviation | hr | 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) |
|
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| Primary | To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5 of 8). | • AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (hr*ng/mL) | The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing. | Posted | Mean | Standard Deviation | hr*ng/mL | 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) |
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| Primary | To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6 of 8). | • AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (hr*ng/mL) | The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing. | Posted | Mean | Standard Deviation | hr*ng/mL | 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) |
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| Primary | To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 8). | • CL/F: apparent clearance (mL/hr). | The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing. | Posted | Mean | Standard Deviation | mL/hr | 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) |
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| Primary | To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (8 of 8). | • Vz/F: apparent volume of distribution (mL). | The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing. | Posted | Mean | Standard Deviation | mL | 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 7). | • Treatment emergent AEs (TEAEs) | The Safety population included all subjects who have received at least 1 dose of study drug. | Posted | Count of Participants | Participants | 4 weeks (first dose of study drug and up to 30 days after the date of the last dose of study drug) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 7). | • Serious adverse events (SAEs) | The Safety population included all subjects who have received at least 1 dose of study drug. | Posted | Count of Participants | Participants | 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 7). | • Withdrawals due to AEs | The Safety population included all subjects who have received at least 1 dose of study drug. | Posted | Count of Participants | Participants | 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 7). | • Deaths | The Safety population included all subjects who have received at least 1 dose of study drug. | Posted | Count of Participants | Participants | 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.1 of 7). | • Changes in vital sign measurements: Temperature (degrees C). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | degrees C | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.2 of 7). | • Changes in vital sign measurements: Pulse Rate (beats/min). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | beats/min | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.3 of 7). | • Changes in vital sign measurements: Respiratory Rate (breaths/min). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | breaths/min | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.4 of 7). | • Changes in vital sign measurements: Systolic Blood Pressure (mmHg). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | mmHg | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.5 of 7). | • Changes in vital sign measurements: Diastolic Blood Pressure (mmHg). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | mmHg | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.1 of 7). | • Changes in clinical laboratory results: Hematology - Hematocrit (L/L). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | L/L | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.2 of 7). | • Changes in clinical laboratory results: Hematology - Hemoglobin (g/L). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | g/L | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.3 of 7). | • Changes in clinical laboratory results: Hematology - Platelet Count (10^9/L). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | 10^9/L | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.4 of 7). | • Changes in clinical laboratory results: Hematology - White Blood Cells (10^9/L). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | 10^9/L | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.5 of 7). | • Changes in clinical laboratory results: Hematology - Basophils (%). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | % Basophils | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.6 of 7). | • Changes in clinical laboratory results: Hematology - Eosinophils (%). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | % Eosinophils | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.7 of 7). | • Changes in clinical laboratory results: Hematology - Neutrophils (%). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | % Neutrophils | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.8 of 7). | • Changes in clinical laboratory results: Hematology - Lymphocytes (%). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | % Lymphocytes | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.9 of 7). | • Changes in clinical laboratory results: Hematology - Monocytes (%). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | % Monocytes | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.10 of 7). | • Changes in clinical laboratory results: Chemistry - Albumin (g/L). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | g/L | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.11 of 7). | • Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | U/L | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.12 of 7). | • Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | U/L | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.13 of 7). | • Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | U/L | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.14 of 7). | • Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | mmol/L | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.15 of 7). | • Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | umol/L | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.16 of 7). | • Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | mmol/L | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.17 of 7). | • Changes in clinical laboratory results: Chemistry - Chloride (mmol/L). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | mmol/L | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.18 of 7). | • Changes in clinical laboratory results: Chemistry - Creatinine (umol/L). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | umol/L | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.19 of 7). | • Changes in clinical laboratory results: Chemistry - Glucose (mmol/L). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | mmol/L | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.20 of 7). | • Changes in clinical laboratory results: Chemistry - LDH (U/L). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | U/L | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.21 of 7). | • Changes in clinical laboratory results: Chemistry - Potassium (mmol/L). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | mmol/L | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.22 of 7). | • Changes in clinical laboratory results: Chemistry - Sodium (mmol/L). | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | mmol/L | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.23 of 7). | • Changes in clinical laboratory results: Urinalysis - pH. | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | pH | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.24 of 7). | • Changes in clinical laboratory results: Urinalysis - Specific Gravity. | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Mean | Standard Deviation | Specific Gravity | 4 weeks (signed informed consent/assent to the final visit) |
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| Secondary | To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 7). | • Physical examination findings including abnormal clinically significant findings | The Safety population included all subjects who have received at least 1 dose of study drug. The data presented is any new or worsened clinically significant abnormal change from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug. | Posted | Count of Participants | Participants | 4 weeks (signed informed consent/assent to the final visit) |
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| 2 |
| 51 |
| 8 |
| 51 |
| Dehydration | Metabolism and nutrition disorders |
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The PI agrees that sponsor shall have the right to the first publication of the study results which is intended to be a joint, multi-center publication. Following the first publication, the PI may publish study data or results, provided however PI submits the proposed publication to sponsor for review at least 60 days prior to the date of the proposed publication. Sponsor may remove any information that is considered confidential and / or proprietary other than study data.
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| Change from Baseline to Final Visit (degrees C) |
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| Change from Baseline to Final Visit (10^9/L) |
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