Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age

Study Overview
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Brief Summary
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The purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children ages 6 to <17 years experiencing mild to moderate acute postoperative pain.

Official Title
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A Phase IIA, Open-Label, Safety and Pharmacokinetic Study of Diclofenac Capsules in Pediatric Subjects 6 to <17 Years of Age With Mild to Moderate Acute Postoperative Pain Following Elective Surgery

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Diclofenac Capsules low dose
* Drug: Diclofenac Capsules high dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body weight ≥18 kilograms. Mild to moderate acute pain requiring treatment with analgesic medication. Willing to have blood samples taken for PK sampling using an indwelling catheter. Must be able to swallow capsules and can tolerate oral medication. For females: is not of reproductive potential (defined as premenarchal) or is practicing an acceptable method of birth control Exclusion Criteria: Severe acute pain Chronic analgesic or glucocorticoid use for any condition within 6 months before dosing with study drug. Emergency surgery History of allergic reaction, hypersensitivity, or clinically significant intolerance to diclofenac, aspirin, codeine, acetaminophen, or any NSAID History of peptic ulcer disease or a GI event (eg, perforation, obstruction, or bleed) within 6 months before screening Current use of any medication that may cause a clinically significant drug interaction when co-administered with diclofenac Current use of any medication that might affect the pharmacokinetics of diclofenac History of bleeding disorders . Developmental delay or behavioral problems that would make it difficult to assess pain. Impaired liver function Clinically significant renal or cardiovascular disease Any medical condition that compromises ability to swallow, absorb, metabolize, or excrete the study drug Previously received any investigational product or device within 30 days before Screening or scheduled to receive an investigational device or another investigational drug (other than that in this study) during the course of this study. Previous participation in this clinical study or currently taking diclofenac.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac Capsules low dose<br>Diclofenac Capsules low dose three times daily for up to three days | Drug: Diclofenac Capsules low dose<br> <br> |
| Experimental: Diclofenac Capsules high dose<br>Diclofenac Capsules high dose three times daily for up to three days | Drug: Diclofenac Capsules high dose<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration of Diclofenac | The estimated typical value for clearance (tvCl) following a single diclofenac dose based on population pharmacokinetic (PopPK) modeling using sparse plasma concentration data in pediatric subjects. | 0-6 hours after first dose of diclofenac | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Diclofenac Capsules Low Dose and High Dose as Assessed by the Incidence of Adverse Events From Baseline to Day 3 or Early Termination |  | Baseline to Day 3/Early Termination |