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

Completed · Phase 3

Conditions studied: Postoperative Pain

In brief

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.

Key facts

Study ID

NCT00801398

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

58

Starts

2009-02-17

Expected to finish

2011-04-18

Last updated by the study team

2019-02-27

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Stanford University School of Medicine — Stanford, California, United States
• The Children's Hospital — Aurora, Colorado, United States
• Children's Research Institute — Washington D.C., District of Columbia, United States
• St. Joseph's Children's Hospital of Tampa — Tampa, Florida, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Hershey Medical Center — Hershey, Pennsylvania, United States
• The Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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