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

Status:	Completed
Conditions:	Post-Surgical Pain
Therapuetic Areas:	Musculoskeletal
Healthy:	No
Age Range:	12 - 17
Updated:	3/1/2019
Start Date:	February 17, 2009
End Date:	April 18, 2011

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

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.

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

We found this trial at

sites

UT Southwestern Medical Center

5323 Harry Hines Blvd
Dallas, Texas 75235

(214) 648-3111