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

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: Oxymorphone ER

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Opana ER, Opana

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose	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.	Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken	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.	Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose	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.	Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues	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.	Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses	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.	Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)

Collaborators and Investigators

• Sponsor: Endo Pharmaceuticals
• Investigators: Study Director: Sr. Director CR&D, Endo Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 17, 2008
• Primary Completion (ACTUAL): February 22, 2010
• Study Completion (ACTUAL): February 22, 2010

Study Registration Dates

• First Submitted: October 2, 2008
• First Submitted That Met QC Criteria: October 2, 2008
• First Posted (ESTIMATE): October 3, 2008

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Pediatric; Malignant; Opioid tolerant; Male 6-17 years of age; Female 6-17 years of age; Non malignant
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Oxymorphone
• Other Study ID Numbers: EN3202 036