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

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ClinicalTrials.gov Identifier: NCT01206907
Recruitment Status : Withdrawn (The study is no longer required for the PREA for this product.)
First Posted : September 22, 2010
Last Update Posted : August 17, 2012
Information provided by:
Endo Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: oxymorphone IR Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Intervention Details:
    Drug: oxymorphone IR
    oxymorphone IR liquid

Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate. [ Time Frame: weekly for 1 month during titration ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Sr. Director CR & D, Endo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01206907     History of Changes
Other Study ID Numbers: EN3319-301
First Posted: September 22, 2010    Key Record Dates
Last Update Posted: August 17, 2012
Last Verified: August 2012

Keywords provided by Endo Pharmaceuticals:
sickle cell anemia
juvenile rheumatoid arthritis
burn victim
Chronic pain of malignant or non-malignant etiology

Additional relevant MeSH terms:
Chronic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia