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Completed

NCT Number: NCT01982539

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

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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Key information

Conditions

Pain Acute Pain Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sheffield, Alabama, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Diclofenac

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Depomed

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 13, 2013
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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