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Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects

Primary Purpose

Chronic Pain

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
oxymorphone IR
Sponsored by
Endo Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring sickle cell anemia, juvenile rheumatoid arthritis, burn victim, cancer, Chronic pain of malignant or non-malignant etiology

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males or females 2 to ≤6 years of age, inclusive
  2. Chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose >1 mg/kg qd oral morphine equivalent)
  3. Expected to continue to require a strong opioid for pain relief for at least 4 months
  4. Able to swallow the oxymorphone HCl immediate-release oral liquid
  5. Have been informed of the nature of the study and informed consent and assent by minor (if IRB required) has been obtained from the legally responsible parent/legal guardian in accordance with IRB requirements

Exclusion Criteria:

  1. Known allergy to, or a significant reaction to, oxymorphone or another opioid
  2. Life expectancy <4 months
  3. Any clinical condition in the investigator's opinion that would preclude participation
  4. Plan to undergo a surgical procedure within 1 month of study entry or anytime during study
  5. Currently prescribed a long-acting opioid (eg., Kadian® morphine sulfate extended release) as part of their analgesic regimen
  6. Received any investigational medication within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than oxymorphone during the course of the study
  7. An ileostomy
  8. Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study medication
  9. Investigator anticipates that the subject would be unable to comply with the protocol
  10. Parent/legal guardian is unable to complete the subject's daily study medication diary
  11. Parent/legal guardian is unable to effectively communicate the subject's status to the investigator

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.
    Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.

    Secondary Outcome Measures

    Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.
    Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.

    Full Information

    First Posted
    September 17, 2010
    Last Updated
    August 15, 2012
    Sponsor
    Endo Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01206907
    Brief Title
    Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects
    Official Title
    AN OPEN-LABEL, NON-RANDOMIZED, MULTICENTER EFFECTIVENESS, SAFETY AND TOLERABILITY STUDY OF OXYMORPHONE HCl IMMEDIATE-RELEASE ORAL LIQUID IN OPIOID-TOLERANT PEDIATRIC SUBJECTS WITH CHRONIC PAIN REQUIRING AN AROUND THE CLOCK OPIOID
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study is no longer required for the PREA for this product.
    Study Start Date
    October 2010 (undefined)
    Primary Completion Date
    December 2013 (Anticipated)
    Study Completion Date
    December 2013 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Endo Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having severe to moderate chronic pain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain
    Keywords
    sickle cell anemia, juvenile rheumatoid arthritis, burn victim, cancer, Chronic pain of malignant or non-malignant etiology

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    oxymorphone IR
    Intervention Description
    oxymorphone IR liquid
    Primary Outcome Measure Information:
    Title
    Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.
    Time Frame
    weekly for 1 month during titration
    Title
    Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.
    Time Frame
    bi-weekly for three months in the maintenance phase
    Secondary Outcome Measure Information:
    Title
    Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.
    Time Frame
    weekly for 1 month during titration
    Title
    Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.
    Time Frame
    bi-weekly for 3 months in the maintenance phase

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males or females 2 to ≤6 years of age, inclusive Chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose >1 mg/kg qd oral morphine equivalent) Expected to continue to require a strong opioid for pain relief for at least 4 months Able to swallow the oxymorphone HCl immediate-release oral liquid Have been informed of the nature of the study and informed consent and assent by minor (if IRB required) has been obtained from the legally responsible parent/legal guardian in accordance with IRB requirements Exclusion Criteria: Known allergy to, or a significant reaction to, oxymorphone or another opioid Life expectancy <4 months Any clinical condition in the investigator's opinion that would preclude participation Plan to undergo a surgical procedure within 1 month of study entry or anytime during study Currently prescribed a long-acting opioid (eg., Kadian® morphine sulfate extended release) as part of their analgesic regimen Received any investigational medication within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than oxymorphone during the course of the study An ileostomy Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study medication Investigator anticipates that the subject would be unable to comply with the protocol Parent/legal guardian is unable to complete the subject's daily study medication diary Parent/legal guardian is unable to effectively communicate the subject's status to the investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects

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