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Trial record 12 of 454 for:    DICLOFENAC

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

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ClinicalTrials.gov Identifier: NCT02287350
Recruitment Status : Completed
First Posted : November 10, 2014
Results First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Depomed

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Intervention Drug: diclofenac potassium oral solution
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 51
Completed 48
Not Completed 3
Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants
6.4  (3.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
28
  54.9%
Male
23
  45.1%
1.Primary Outcome
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).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cmax (ng/mL) Number Analyzed 18 participants
433.9  (297.53)
pre-dose concentrations (ng/mL) Number Analyzed 18 participants
0.000  (0.0000)
15 min post-dose concentrations (ng/mL) Number Analyzed 17 participants
378.471  (315.3756)
30 min post-dose concentrations (ng/mL) Number Analyzed 19 participants
260.484  (161.9306)
60 min post-dose concentrations (ng/mL) Number Analyzed 18 participants
178.544  (108.9297)
2 hrs post-dose concentrations (ng/mL) Number Analyzed 18 participants
67.394  (54.5705)
4 hrs post-dose concentrations (ng/mL) Number Analyzed 18 participants
22.964  (21.4744)
6 hrs post-dose concentrations (ng/mL) Number Analyzed 17 participants
15.042  (13.0339)
2.Primary Outcome
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).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 18
Median (Full Range)
Unit of Measure: hr
0.250
(0.22 to 1.08)
3.Primary Outcome
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).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: 1/hr
0.47329  (0.141463)
4.Primary Outcome
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).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: hr
1.692  (0.8811)
5.Primary Outcome
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).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
454.544  (219.3114)
6.Primary Outcome
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).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: hr*ng/mL
491.915  (244.0359)
7.Primary Outcome
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).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: mL/hr
25927.177  (12582.7293)
8.Primary Outcome
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).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.
Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: mL
66845.275  (64351.3897)
9.Secondary Outcome
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).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all subjects who have received at least 1 dose of study drug.
Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
16
  31.4%
10.Secondary Outcome
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).
Hide Description • Serious adverse events (SAEs)
Time Frame 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all subjects who have received at least 1 dose of study drug.
Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
2
   3.9%
11.Secondary Outcome
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).
Hide Description • Withdrawals due to AEs
Time Frame 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all subjects who have received at least 1 dose of study drug.
Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
12.Secondary Outcome
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).
Hide Description • Deaths
Time Frame 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all subjects who have received at least 1 dose of study drug.
Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
13.Secondary Outcome
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).
Hide Description • Changes in vital sign measurements: Temperature (degrees C).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: degrees C
Baseline (degrees C) Number Analyzed 51 participants
36.94  (0.485)
Final Visit (degrees C) Number Analyzed 47 participants
36.67  (0.492)
Change from Baseline to Final Visit (degrees C) Number Analyzed 47 participants
-0.29  (0.511)
14.Secondary Outcome
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).
Hide Description • Changes in vital sign measurements: Pulse Rate (beats/min).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: beats/min
Baseline (beats/min) Number Analyzed 51 participants
103.7  (24.41)
Final Visit (beats/min) Number Analyzed 47 participants
93.4  (16.61)
Change from Baseline to Final Visit (beats/min) Number Analyzed 47 participants
-10.5  (17.91)
15.Secondary Outcome
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).
Hide Description • Changes in vital sign measurements: Respiratory Rate (breaths/min).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: breaths/min
Baseline (breaths/min) Number Analyzed 51 participants
19.7  (3.55)
Final Visit (breaths/min) Number Analyzed 47 participants
19.0  (2.90)
Change from Baseline to Final Visit (breaths/min) Number Analyzed 47 participants
-0.9  (3.93)
16.Secondary Outcome
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).
Hide Description • Changes in vital sign measurements: Systolic Blood Pressure (mmHg).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline (mmHg) Number Analyzed 51 participants
110.8  (15.29)
Final Visit (mmHg) Number Analyzed 47 participants
106.6  (13.08)
Change from Baseline to Final Visit (mmHg) Number Analyzed 47 participants
-4.5  (15.45)
17.Secondary Outcome
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).
Hide Description • Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline (mmHg) Number Analyzed 51 participants
70.1  (12.39)
Final Visit (mmHg) Number Analyzed 47 participants
65.1  (10.86)
Change from Baseline to Final Visit (mmHg) Number Analyzed 47 participants
-5.2  (13.81)
18.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Hematology - Hematocrit (L/L).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: L/L
Baseline (L/L) Number Analyzed 51 participants
0.357  (0.0264)
Final Visit (L/L) Number Analyzed 43 participants
0.363  (0.0290)
Change from Baseline to Final Visit (L/L) Number Analyzed 43 participants
0.006  (0.0269)
19.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: g/L
Baseline (g/L) Number Analyzed 51 participants
120.5  (10.55)
Final Visit (g/L) Number Analyzed 43 participants
121.0  (10.69)
Change from Baseline to Final Visit (g/L) Number Analyzed 43 participants
0.4  (8.20)
20.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Hematology - Platelet Count (10^9/L).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: 10^9/L
Baseline (10^9/L) Number Analyzed 51 participants
315.2  (62.79)
Final Visit (10^9/L) Number Analyzed 43 participants
402.2  (109.11)
Change from Baseline to Final Visit (10^9/L) Number Analyzed 43 participants
85.6  (112.28)
21.Secondary Outcome
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).
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: 10^9/L
Baseline (10^9/L) Number Analyzed 51 participants
8.749  (4.7523)
Final Visit (10^9/L) Number Analyzed 43 participants
8.807  (2.2423)
Change from Baseline to Final Visit (10^9/L) Number Analyzed 43 participants
-0.054  (4.7766)
22.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Hematology - Basophils (%).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: % Basophils
Baseline (% Basophils) Number Analyzed 50 participants
0.414  (0.3068)
Final Visit (% Basophils) Number Analyzed 42 participants
0.496  (0.3150)
Change from Baseline to Final Visit (% Basophils) Number Analyzed 41 participants
0.085  (0.2466)
23.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Hematology - Eosinophils (%).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: % Eosinophils
Baseline (% Eosinophils) Number Analyzed 50 participants
3.911  (3.2009)
Final Visit (% Eosinophils) Number Analyzed 42 participants
4.514  (3.1678)
Change from Baseline to Final Visit(% Eosinophils) Number Analyzed 41 participants
0.532  (2.9069)
24.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Hematology - Neutrophils (%).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: % Neutrophils
Baseline (% Neutrophils) Number Analyzed 50 participants
49.649  (15.1446)
Final Visit (% Neutrophils) Number Analyzed 42 participants
48.740  (11.1360)
Change from Baseline to Final Visit(% Neutrophils) Number Analyzed 41 participants
-0.791  (17.9732)
25.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Hematology - Lymphocytes (%).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: % Lymphocytes
Baseline (% Lymphocytes) Number Analyzed 50 participants
37.195  (12.4809)
Final Visit (% Lymphocytes) Number Analyzed 42 participants
38.186  (10.4428)
Change from Baseline to Final Visit(% Lymphocytes) Number Analyzed 41 participants
0.866  (16.2141)
26.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Hematology - Monocytes (%).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: % Monocytes
Baseline (% Monocytes) Number Analyzed 50 participants
8.569  (2.9774)
Final Visit (% Monocytes) Number Analyzed 42 participants
7.859  (2.3952)
Change from Baseline to Final Visit (% Monocytes) Number Analyzed 41 participants
-0.643  (3.0825)
27.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Chemistry - Albumin (g/L).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: g/L
Baseline (g/L) Number Analyzed 51 participants
40.882  (4.7314)
Final Visit (g/L) Number Analyzed 44 participants
42.341  (5.2205)
Change from Baseline to Final Visit (g/L) Number Analyzed 44 participants
1.114  (3.9131)
28.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (U/L) Number Analyzed 51 participants
219.471  (60.3173)
Final Visit (U/L) Number Analyzed 44 participants
206.545  (54.2160)
Change from Baseline to Final Visit (U/L) Number Analyzed 44 participants
-10.614  (29.3505)
29.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (U/L) Number Analyzed 51 participants
21.569  (21.0364)
Final Visit (U/L) Number Analyzed 44 participants
17.727  (11.5383)
Change from Baseline to Final Visit (U/L) Number Analyzed 44 participants
-1.136  (9.0928)
30.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (U/L) Number Analyzed 51 participants
29.392  (11.4001)
Final Visit (U/L) Number Analyzed 44 participants
25.818  (5.5793)
Change from Baseline to Final Visit (U/L) Number Analyzed 44 participants
-2.568  (11.1426)
31.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (mmol/L) Number Analyzed 51 participants
23.590  (2.1776)
Final Visit (mmol/L) Number Analyzed 44 participants
24.748  (2.2748)
Change from Baseline to Final Visit (mmol/L) Number Analyzed 44 participants
1.109  (2.5307)
32.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: umol/L
Baseline (umol/L) Number Analyzed 51 participants
4.695  (2.3525)
Final Visit (umol/L) Number Analyzed 44 participants
4.042  (2.8647)
Change from Baseline to Final Visit (umol/L) Number Analyzed 44 participants
-0.319  (3.3429)
33.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (mmol/L) Number Analyzed 51 participants
4.241  (1.4054)
Final Visit (mmol/L) Number Analyzed 44 participants
4.380  (1.4918)
Change from Baseline to Final Visit (mmol/L) Number Analyzed 44 participants
0.326  (1.4264)
34.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (mmol/L) Number Analyzed 51 participants
102.959  (3.2785)
Final Visit (mmol/L) Number Analyzed 44 participants
101.839  (3.1748)
Change from Baseline to Final Visit (mmol/L) Number Analyzed 44 participants
-0.773  (2.7935)
35.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: umol/L
Baseline (umol/L) Number Analyzed 51 participants
32.032  (13.0954)
Final Visit (umol/L) Number Analyzed 44 participants
35.260  (12.4928)
Change from Baseline to Final Visit (umol/L) Number Analyzed 44 participants
4.159  (8.3375)
36.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (mmol/L) Number Analyzed 49 participants
5.167  (0.7358)
Final Visit (mmol/L) Number Analyzed 44 participants
4.851  (0.9318)
Change from Baseline to Final Visit (mmol/L) Number Analyzed 42 participants
-0.361  (0.9477)
37.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Chemistry - LDH (U/L).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline (U/L) Number Analyzed 47 participants
253.085  (75.9762)
Final Visit (U/L) Number Analyzed 42 participants
253.071  (84.4854)
Change from Baseline to Final Visit (U/L) Number Analyzed 39 participants
-1.256  (100.1911)
38.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (mmol/L) Number Analyzed 51 participants
4.366  (0.4274)
Final Visit (mmol/L) Number Analyzed 43 participants
4.337  (0.6764)
Change from Baseline to Final Visit (mmol/L) Number Analyzed 43 participants
-0.038  (0.7428)
39.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: mmol/L
Baseline (mmol/L) Number Analyzed 51 participants
138.510  (2.7230)
Final Visit (mmol/L) Number Analyzed 44 participants
139.818  (2.6787)
Change from Baseline to Final Visit (mmol/L) Number Analyzed 44 participants
1.409  (2.8228)
40.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Urinalysis - pH.
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: pH
Baseline (pH) Number Analyzed 32 participants
6.281  (0.6214)
Final Visit (pH) Number Analyzed 41 participants
6.598  (0.8079)
Change from Baseline to Final Visit (pH) Number Analyzed 29 participants
0.276  (0.8720)
41.Secondary Outcome
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).
Hide Description • Changes in clinical laboratory results: Urinalysis - Specific Gravity.
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: Specific Gravity
Baseline (Specific Gravity) Number Analyzed 32 participants
1.022  (0.0077)
Final Visit (Specific Gravity) Number Analyzed 41 participants
1.020  (0.0065)
Change from Baseline to Final Visit (Spec.Gravity) Number Analyzed 29 participants
0.000  (0.0068)
42.Secondary Outcome
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).
Hide Description • Physical examination findings including abnormal clinically significant findings
Time Frame 4 weeks (signed informed consent/assent to the final visit)
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 51
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.0%
Time Frame 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)
Adverse Event Reporting Description The Safety population included all subjects who have received at least 1 dose of study drug.
 
Arm/Group Title Diclofenac Potassium Oral Solution
Hide Arm/Group Description

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.

All-Cause Mortality
Diclofenac Potassium Oral Solution
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Diclofenac Potassium Oral Solution
Affected / at Risk (%)
Total   2/51 (3.92%) 
Injury, poisoning and procedural complications   
Wound Secretion  1/51 (1.96%) 
Metabolism and nutrition disorders   
Dehydration  1/51 (1.96%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Diclofenac Potassium Oral Solution
Affected / at Risk (%)
Total   8/51 (15.69%) 
General disorders   
Pyrexia  8/51 (15.69%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Operations
Organization: Depomed
Phone: 510-744-8000
EMail: clinicaltrials@depomed.com
Layout table for additonal information
Responsible Party: Depomed
ClinicalTrials.gov Identifier: NCT02287350     History of Changes
Other Study ID Numbers: 81-0074
First Submitted: October 27, 2014
First Posted: November 10, 2014
Results First Submitted: January 25, 2017
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017