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

Endo Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: Oxymorphone IR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00801398

EN3203-010

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

Oxymorphone IR

Experimental group

Description:

Open-Label, 2 part ascending-dose multicenter study

Treatment:

Drug: Oxymorphone IR