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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 Description
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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.

Condition or disease Intervention/treatment Phase
Pain Drug: diclofenac potassium oral solution Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arms and Interventions
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Arm Intervention/treatment
Experimental: diclofenac potassium oral solution
5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.
 Drug: diclofenac potassium oral solution
Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain.
Other Name: diclofenac


Outcome Measures
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Primary Outcome Measures :
  1. 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). [ Time Frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) ]
    • Cmax: maximum concentration (ng/mL)

  2. 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). [ Time Frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) ]
    • Tmax: time to maximum concentration (hr)

  3. 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). [ Time Frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) ]
    • λz: elimination rate constant (1/hr)

  4. 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). [ Time Frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) ]
    • t1/2: terminal elimination half-life (hr)

  5. 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). [ Time Frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) ]
    • 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)

  6. 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). [ Time Frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) ]
    • AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (hr*ng/mL)

  7. 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). [ Time Frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) ]
    • CL/F: apparent clearance (mL/hr).

  8. 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). [ Time Frame: 6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose) ]
    • Vz/F: apparent volume of distribution (mL).


Secondary Outcome Measures :
  1. 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). [ Time Frame: 4 weeks (first dose of study drug and up to 30 days after the date of the last dose of study drug) ]
    • Treatment emergent AEs (TEAEs)

  2. 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). [ Time Frame: 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug) ]
    • Serious adverse events (SAEs)

  3. 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). [ Time Frame: 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug) ]
    • Withdrawals due to AEs

  4. 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). [ Time Frame: 4 weeks (signed informed consent/assent to 30 days after the last dose of study drug) ]
    • Deaths

  5. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in vital sign measurements: Temperature (degrees C).

  6. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in vital sign measurements: Pulse Rate (beats/min).

  7. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in vital sign measurements: Respiratory Rate (breaths/min).

  8. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in vital sign measurements: Systolic Blood Pressure (mmHg).

  9. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).

  10. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Hematology - Hematocrit (L/L).

  11. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).

  12. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Hematology - Platelet Count (10^9/L).

  13. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Hematology - White Blood Cells (10^9/L).

  14. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Hematology - Basophils (%).

  15. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Hematology - Eosinophils (%).

  16. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Hematology - Neutrophils (%).

  17. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Hematology - Lymphocytes (%).

  18. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Hematology - Monocytes (%).

  19. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Chemistry - Albumin (g/L).

  20. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).

  21. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).

  22. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).

  23. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).

  24. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).

  25. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).

  26. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).

  27. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).

  28. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).

  29. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Chemistry - LDH (U/L).

  30. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).

  31. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).

  32. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Urinalysis - pH.

  33. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Changes in clinical laboratory results: Urinalysis - Specific Gravity.

  34. 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). [ Time Frame: 4 weeks (signed informed consent/assent to the final visit) ]
    • Physical examination findings including abnormal clinically significant findings


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02287350


Locations
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United States, Alabama
Sheffield, Alabama, United States
United States, California
Stanford, California, United States
United States, Missouri
Saint Peters, Missouri, United States
United States, Texas
Dallas, Texas, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Depomed
More Information
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Responsible Party: Depomed
ClinicalTrials.gov Identifier: NCT02287350    
Other Study ID Numbers: 81-0074
First Posted: November 10, 2014    Key Record Dates
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017
Last Verified: June 2017
Keywords provided by Depomed:
pain
moderate pain
mild pain
acute pain
mild acute pain
 moderate acute pain
mild or moderate acute pain
NSAID
nonsteroidal anti-inflammatory drug
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Pain
Pain
Neurologic Manifestations
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action