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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Zipsor®

• Registration Number: NCT01982539
• Lead Sponsor: Depomed

Brief Summary

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

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

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-06
• Study First Posted: 2013-11-13
• Primary Completion: 2014-05
• Study Completion: 2014-09
• Results First Submitted: 2015-04-30
• Results First Submitted QC: 2015-04-30
• Results First Posted: 2015-05-15
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-27
• Last Update Posted: 2020-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zipsor® (Liquid filled capsules)	Zipsor®	25mg/every 6hrs/up to 4 days treatment

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years	First dose to 30 days after the last dose	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

Secondary Outcome Measures

Name	Time	Method
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.	From Baseline to 1st and 2nd hour	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.
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.	From Baseline to 1st and 2nd hour	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.