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Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain

Primary Purpose

Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
diclofenac potassium oral solution
Sponsored by
Depomed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pain, moderate pain, mild pain, acute pain, mild acute pain, moderate acute pain, mild or moderate acute pain, NSAID, nonsteroidal anti-inflammatory drug

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female subjects between 2-12 years of age.
  • Subjects must be post-op, having mild or moderate acute pain.

Other inclusions apply.

Exclusion Criteria:

  • Subject has a known history of allergic reaction, hypersensitivity to diclofenac, aspirin, acetaminophen, or reaction to the non-active ingredients of the study medication.
  • Subject has been taking analgesics for 48-72 hours prior to Screening.
  • Subject has a history of any GI event greater than 6 months before Screening.
  • Subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac or acetaminophen.
  • Subject is requiring treatment for pre-existing hypertension.

Other exclusions apply.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

diclofenac potassium oral solution

Arm Description

5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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)
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)
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).
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).

Secondary Outcome Measures

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)
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)
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
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
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).
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).
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).
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).
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).
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).
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).
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).
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).
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 (%).
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 (%).
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 (%).
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 (%).
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 (%).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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.
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.
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

Full Information

First Posted
October 27, 2014
Last Updated
June 12, 2017
Sponsor
Depomed
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1. Study Identification

Unique Protocol Identification Number
NCT02287350
Brief Title
Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain
Official Title
A Phase 4, Open-Label Study of the Pharmacokinetics and Safety of Diclofenac Potassium Oral Solution in Pediatric Subjects (Ages 2-12 Years) With Mild to Moderate Acute Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Depomed

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
pain, moderate pain, mild pain, acute pain, mild acute pain, moderate acute pain, mild or moderate acute pain, NSAID, nonsteroidal anti-inflammatory drug

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diclofenac potassium oral solution
Arm Type
Experimental
Arm Description
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
Intervention Type
Drug
Intervention Name(s)
diclofenac potassium oral solution
Other Intervention Name(s)
diclofenac
Intervention Description
Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain.
Primary Outcome Measure Information:
Title
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).
Description
• Cmax: maximum concentration (ng/mL)
Time Frame
6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
Title
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).
Description
• Tmax: time to maximum concentration (hr)
Time Frame
6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
Title
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).
Description
• λz: elimination rate constant (1/hr)
Time Frame
6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
Title
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).
Description
• t1/2: terminal elimination half-life (hr)
Time Frame
6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
Title
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).
Description
• 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)
Time Frame
6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
Title
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).
Description
• AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (hr*ng/mL)
Time Frame
6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
Title
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).
Description
• CL/F: apparent clearance (mL/hr).
Time Frame
6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
Title
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).
Description
• Vz/F: apparent volume of distribution (mL).
Time Frame
6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)
Secondary Outcome Measure Information:
Title
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).
Description
• Treatment emergent AEs (TEAEs)
Time Frame
4 weeks (first dose of study drug and up to 30 days after the date of the last dose of study drug)
Title
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).
Description
• Serious adverse events (SAEs)
Time Frame
4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)
Title
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).
Description
• Withdrawals due to AEs
Time Frame
4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)
Title
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).
Description
• Deaths
Time Frame
4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)
Title
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).
Description
• Changes in vital sign measurements: Temperature (degrees C).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in vital sign measurements: Pulse Rate (beats/min).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in vital sign measurements: Respiratory Rate (breaths/min).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in vital sign measurements: Systolic Blood Pressure (mmHg).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Hematology - Hematocrit (L/L).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Hematology - Platelet Count (10^9/L).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Hematology - White Blood Cells (10^9/L).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Hematology - Basophils (%).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Hematology - Eosinophils (%).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Hematology - Neutrophils (%).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Hematology - Lymphocytes (%).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Hematology - Monocytes (%).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Chemistry - Albumin (g/L).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Chemistry - LDH (U/L).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Urinalysis - pH.
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Changes in clinical laboratory results: Urinalysis - Specific Gravity.
Time Frame
4 weeks (signed informed consent/assent to the final visit)
Title
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).
Description
• Physical examination findings including abnormal clinically significant findings
Time Frame
4 weeks (signed informed consent/assent to the final visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects between 2-12 years of age. Subjects must be post-op, having mild or moderate acute pain. Other inclusions apply. Exclusion Criteria: Subject has a known history of allergic reaction, hypersensitivity to diclofenac, aspirin, acetaminophen, or reaction to the non-active ingredients of the study medication. Subject has been taking analgesics for 48-72 hours prior to Screening. Subject has a history of any GI event greater than 6 months before Screening. Subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac or acetaminophen. Subject is requiring treatment for pre-existing hypertension. Other exclusions apply.
Facility Information:
City
Sheffield
State/Province
Alabama
Country
United States
City
Stanford
State/Province
California
Country
United States
City
Saint Peters
State/Province
Missouri
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain

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