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

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ClinicalTrials.gov Identifier: NCT01982539
Recruitment Status : Completed
First Posted : November 13, 2013
Results First Posted : May 15, 2015
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Zipsor® Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

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 Name: Diclofenac




Primary Outcome Measures :
  1. To Confirm the 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


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: From Baseline to 1st and 2nd hour ]
    To determine efficacy by assessing percent changes of 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.



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982539


Locations
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United States, Alabama
Sheffield, Alabama, United States, 35660
United States, California
Stanford, California, United States, 94305-5640
Sponsors and Collaborators
Depomed

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Responsible Party: Depomed
ClinicalTrials.gov Identifier: NCT01982539     History of Changes
Other Study ID Numbers: 81-0072
First Posted: November 13, 2013    Key Record Dates
Results First Posted: May 15, 2015
Last Update Posted: May 15, 2015
Last Verified: September 2014
Keywords provided by Depomed:
pain
NSAID
moderate pain
mild pain
acute pain
mild acute pain
moderate acute pain
mild or moderate acute pain
Additional relevant MeSH terms:
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Diclofenac
Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action