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

April 27, 2020 updated by: Depomed

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Sheffield, Alabama, United States, 35660
    • California
      • Stanford, California, United States, 94305-5640

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zipsor® (Liquid filled capsules)
25mg/every 6hrs/up to 4 days treatment
Drug: 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.
Other Names:
  • Diclofenac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years
Time Frame: 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
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.
Time Frame: 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.
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Depomed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 1, 2013

First Submitted That Met QC Criteria

November 6, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Actual)

May 7, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81-0072

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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