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

Phase 4CompletedNCT01982539

Depomed25 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain

Interventions

Zipsor®DRUG

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.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (2)

Unnamed facility

Sheffield, Alabama, United States

Unnamed facility

Stanford, California, United States

Outcomes

Primary Outcomes

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

Time frame: First dose to 30 days after the last dose

Secondary Outcomes

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.

Time frame: 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.

Time frame: From Baseline to 1st and 2nd hour

Data from ClinicalTrials.gov

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