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

This study has been withdrawn prior to enrollment.
(The study is no longer required for the PREA for this product.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01206907
First Posted: September 22, 2010
Last Update Posted: August 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Endo Pharmaceuticals
  Purpose
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 Intervention Phase
Chronic Pain Drug: oxymorphone IR Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

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

Enrollment: 0
Study Start Date: October 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: oxymorphone IR
    oxymorphone IR liquid
  Eligibility

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
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

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

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

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