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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-09-30

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.

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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.

Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zipsor® (Liquid filled capsules)

25mg/every 6hrs/up to 4 days treatment

Group Type EXPERIMENTAL

Zipsor®

Intervention Type 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.

Interventions

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Zipsor®

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.

Intervention Type DRUG

Other Intervention Names

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Diclofenac

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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No