Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute

Study Overview
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Brief Summary
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As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects.

Detailed Description
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Open-label study, subjects will be dosed with Zipsor® for the treatment of mild to moderate acute pain for up to 4 days.

Official Title
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An Open-Label Study of the Safety and Efficacy of Zipsor® (Diclofenac Potassium) Liquid Filled Capsules in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute Pain

Conditions
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Pain

Intervention / Treatment
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* Drug: Zipsor®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects between 12-17 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 analgesic 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 has previously participated in another clinical study of Zipsor or taking Zipsor for any other indication. Subject is requiring treatment for pre-existing hypertension. Other exclusions apply.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zipsor® (Liquid filled capsules)<br>25mg/every 6hrs/up to 4 days treatment | Drug: Zipsor®<br>* Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treament. Drug taken by mouth.<br>* Other names: Diclofenac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years | Safety Endpoints: Treatment emergent AEs (TEAEs) Serious adverse events (SAEs) Withdrawals due to AEs Deaths Observed values and changes in vital sign measurements Observed values and changes in clinical laboratory results Physical examination findings | First dose to 30 days after the last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration. | Numeric Pain Rating Scale (NPRS) measures the subject intensity of pain on an 11-point scale. 0 = No Pain, 10 = Worst Pain at baseline to (1) the first hour and (2) the second hour after the first dose of Zipsor® administration. | From Baseline to 1st and 2nd hour | 
| Percentage Difference of Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration. | Numeric Pain Rating Scale (NPRS) measures the subject intensity of pain on an 11-point scale. 0 = No Pain, 10 = Worst Pain at baseline to (1) the first hour and (2) the second hour after the first dose of Zipsor® administration. | From Baseline to 1st and 2nd hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, NSAID, moderate pain, mild pain, acute pain, mild acute pain, moderate acute pain, mild or moderate acute pain