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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
Results First Posted : December 16, 2020
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Description
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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 ER 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
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.
Actual Study Start Date : November 17, 2008
Actual Primary Completion Date : February 22, 2010
Actual Study Completion Date : February 22, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Oxymorphone ER Drug: Oxymorphone ER

Oxymorphone ER dosing adjustments made under the direction of the Investigator during the Titration Period.

Oxymorphone IR (Opana) IR 5mg tablet - used as rescue medications

Other Name: Opana ER, Opana


Outcome Measures
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Primary Outcome Measures :
  1. Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose [ Time Frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) ]
    Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.


Secondary Outcome Measures :
  1. Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken [ Time Frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) ]
    Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.

  2. Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose [ Time Frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) ]
    Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.

  3. Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues [ Time Frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) ]
    Average number of daily rescues per day by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.

  4. Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses [ Time Frame: Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period) ]
    Total number of doses (Tablets) taken by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.


Eligibility Criteria
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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
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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
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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
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Study Director: Sr. Director CR&D Endo Pharmaceuticals
More Information
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Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00765856    
Other Study ID Numbers: EN3202 036
First Posted: October 3, 2008    Key Record Dates
Results First Posted: December 16, 2020
Last Update Posted: December 16, 2020
Last Verified: November 2020
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:
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Chronic Pain
Pain
Neurologic Manifestations
Oxymorphone
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia