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

• ClinicalTrials.gov Identifier: NCT00765856
• Recruitment Status: Terminated
• First Posted: October 3, 2008
• Results First Posted: December 16, 2020
• Last Update Posted: December 16, 2020
• Sponsor: Endo Pharmaceuticals
• Information provided by (Responsible Party): Endo Pharmaceuticals

Tracking Information

• First Submitted Date: October 2, 2008
• First Posted Date: October 3, 2008
• Results First Submitted Date: October 14, 2020
• Results First Posted Date: December 16, 2020
• Last Update Posted Date: December 16, 2020
• Actual Study Start Date: November 17, 2008
• Actual Primary Completion Date: February 22, 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 20, 2020)

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.

• Original Primary Outcome Measures (submitted: October 2, 2008): Change in pain intensity from baseline to last assessment using the FPS-R. [ Time Frame: From baseline up to 4 weeks ]

Current Secondary Outcome Measures (submitted: November 20, 2020)

• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures (submitted: October 2, 2008): Assessment of AEs, vital signs, and physical examinations. [ Time Frame: Duration of the study ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
• Official Title: An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.
• 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.
• 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
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Pain

Intervention

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

Study Arms

Experimental: Oxymorphone ER

Intervention: Drug: Oxymorphone ER

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 5, 2012): 27
• Original Estimated Enrollment (submitted: October 2, 2008): 60
• Actual Study Completion Date: February 22, 2010
• Actual Primary Completion Date: February 22, 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00765856
• Other Study ID Numbers: EN3202 036
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Endo Pharmaceuticals
• Study Sponsor: Endo Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Director: Sr. Director CR&D; Endo Pharmaceuticals

• PRS Account: Endo Pharmaceuticals
• Verification Date: November 2020