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Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects

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.
ClinicalTrials.gov Identifier: NCT00765856
Recruitment Status : Terminated (Terminated new protocol developed which incorporated Pharmacokinetics)
First Posted : October 3, 2008
Last Update Posted : June 12, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject's pain scores. Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain medication (as needed). Titration Period will end when the fixed dose of study medication is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the open-label 3-month maintenance period on the fixed dose of study medication established during the Titration Period.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Oxymorphone IR - Opioid Phase 3

Detailed Description:
An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.
Study Start Date : October 2008
Primary Completion Date : February 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: Opana® ER
Oxymorphone IR - Opioid
Drug: Oxymorphone IR - Opioid
Opana IR 5mg tablet
Other Name: Opana®


Outcome Measures

Primary Outcome Measures :
  1. Change in pain intensity from baseline to last assessment using the FPS-R. [ Time Frame: From baseline up to 4 weeks ]

Secondary Outcome Measures :
  1. Assessment of AEs, vital signs, and physical examinations. [ Time Frame: Duration of the study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have 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 greater than or equal to 45 mg/daily (qd) oral morphine equivalent)
  • Weigh at least 50 kg
  • Expected to continue to require a strong opioid for pain relief for at least 4 weeks and up to 4 months.

Exclusion Criteria:

  • Have a life expectancy <4 weeks
  • Plan to undergo a surgical procedure within 3 days of study entry or during the Titration Period
  • Have dysphagia or difficulty swallowing whole tablets
  • Have a previous exposure to oxymorphone
  • Have an ileostomy
Contacts and Locations

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): NCT00765856


Locations
United States, Arkansas
Arkansas Childrens's Hospital-Division of Pediatric Anestesia and Pain Medicine
Little Rock, Arkansas, United States, 72202
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Colorado
The Children's Hospital
Aurora, Colorado, United States, 80045
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
Florida Institute of Medical Research
Jacksonville, Florida, United States, 32257
Tukoi Clinical Research
Miami, Florida, United States, 34104
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States, 33618
United States, Georgia
Taylor Research, LLC
Marietta, Georgia, United States, 30060
United States, Indiana
Rehabilitation Associates of Indiana
Indianapolis, Indiana, United States, 46250
United States, Kentucky
University of Louisville Reserach Foundation, Inc.
Louisville, Kentucky, United States, 40202
United States, North Carolina
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17112
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Sr. Director CR&D Endo Pharmaceuticals
More Information

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00765856     History of Changes
Other Study ID Numbers: EN3202 036
First Posted: October 3, 2008    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015

Keywords provided by Endo Pharmaceuticals:
Opioid tolerant
Pediatric
Male 6-17 years of age
Female 6-17 years of age
Pain
Non malignant
Malignant

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