Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.

• ClinicalTrials.gov Identifier: NCT00801398
• Recruitment Status: Completed
• First Posted: December 3, 2008
• Results First Posted: February 27, 2019
• Last Update Posted: February 27, 2019
• Sponsor: Endo Pharmaceuticals
• Information provided by (Responsible Party): Endo Pharmaceuticals

Tracking Information

• First Submitted Date: December 2, 2008
• First Posted Date: December 3, 2008
• Results First Submitted Date: December 20, 2018
• Results First Posted Date: February 27, 2019
• Last Update Posted Date: February 27, 2019
• Actual Study Start Date: February 17, 2009
• Actual Primary Completion Date: April 18, 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 1, 2019)

• Summary of Visual Analog Scales (VAS) of Pain Intensity Change From Baseline by Treatment Group With Single Dose of Oxymorphone IR Tablet and Multiple Dose of Oxymorphone IR Tablet [ Time Frame: Single Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h or Rescue; Multiple Dose Timeframe: 15min, 30min, 1h, 2h, 3h, 4h, 6h, subsequent doses every 4-6 hours (Multiple Dose #1-11), and Early Termination ]
  Change from Baseline in 100-mm Visual Analog Scales (VAS) in Multiple Dose of Oxymorphone IR Tablet
• Subjects Taking Rescue Medication [ Time Frame: first dose through 48 hours after first dose ]
  Percentages are based on the number of subjects in each treatment group.

• Original Primary Outcome Measures (submitted: December 2, 2008): During the Single-Dose Period, the safety of oxymorphone IR in children >12-17 years requiring an opioid to treat their acute postoperative pain of various etiologies will be assessed. [ Time Frame: From baseline up to 4 weeks ]

Current Secondary Outcome Measures (submitted: February 1, 2019)

• AUC(0-t) of Single Dose of Oxymorphone by Treatment Group [ Time Frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h ]
  AUC0-t: Area under the concentration versus time curve from time 0 to the last measured concentration (Ct), calculated by linear trapezoidal rule
• AUC(0-inf) of Single Dose of Oxymorphone by Treatment Group [ Time Frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h ]
  AUC0-inf: Area under the concentration versus time curve from time 0 to infinity, calculated as AUC0-t + Ct/terminal rate constant (single-dose period only), where Ct is the concentration at the time of the last quantifiable concentration
• Cmax of Single Dose of Oxymorphone by Treatment Group [ Time Frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h ]
  Cmax: Maximum plasma concentration; the highest concentration observed during a dosage interval
• Tmax of Single Dose of Oxymorphone by Treatment Group [ Time Frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h ]
  Tmax: The time at which Cmax was observed
• Terminal Rate Constant of Single Dose of Oxymorphone by Treatment Group [ Time Frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h ]
  λ: Terminal rate constant, calculated as the negative slope of the ln-linear portion of the terminal plasma concentration-time curve (single-dose period only)
• Terminal Half-life of Single Dose of Oxymorphone by Treatment Group [ Time Frame: Baseline, 2h, 4h, 8h, 12h, 24h, 28h, 32h, 36h and 48h ]
  t½: Terminal half-life, calculated as terminal rate constant/(ln 2) (single-dose period only)

• Original Secondary Outcome Measures: Not Provided
• 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 Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
• Official Title: An Open-Label, Ascending, Two-Part, Single- and Multiple-Dose Evaluation of the Safety, Pharmacokinetics, and Effectiveness of Oxymorphone for Acute Postoperatiave Pain in Pediatric Subjects

Brief Summary

When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40).

This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.

• Detailed Description: Not Provided
• 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: Postoperative Pain

Intervention

Drug: Oxymorphone IR

Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs

Other Name: Opana IR

Study Arms

Experimental: Oxymorphone IR

Open-Label, 2 part ascending-dose multicenter study

Intervention: Drug: Oxymorphone IR

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 1, 2019): 58
• Original Estimated Enrollment (submitted: December 2, 2008): 48
• Actual Study Completion Date: April 18, 2011
• Actual Primary Completion Date: April 18, 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Male or female > 12 to 17 years of age, inclusive
• Weigh at least 50 kg
• Postoperative oral opioid analgesia required for at least 24 hours or 48 hours following postoperataive parenteral analgesia
• Are expected to be hospitalized for the duration of the study

Exclusion Criteria:

• Known allergy to, or a significant reaction to, oxymorphone or another opioid
• Life expectancy of < 4 weeks
• Positive pregnancy test at screening

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 17 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00801398
• Other Study ID Numbers: EN3203-010
• Has Data Monitoring Committee: Yes
• 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: Study Director; Endo Pharmaceuticals

• PRS Account: Endo Pharmaceuticals
• Verification Date: December 2018