Conditions: Postoperative Pain
Keywords: Opioid tolerant Pediatric Pain Non malignant Malignant
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 58
Healthy volunteers: yes

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:

Arms:
arm 1: Open-Label, 2 part ascending-dose multicenter study

Interventions: intervention 1: Oxymorphone IR
Intervention descriptions: intervention 1: Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs

Protocol document: