NCT00801398

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Oxymorphone IR	Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs

Timeline

• Start date: 2009-02-17
• Primary completion: 2011-04-18
• Completion: 2011-04-18
• First posted: 2008-12-03
• Last updated: 2019-02-27
• Results posted: 2019-02-27

Locations

11 sites across 1 country: United States