Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Endo Pharmaceuticals

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the analgesic efficacy and safety of two doses of oxymorphone immediate release (IR) compared to placebo and oxycodone in post-surgical pain.

Research Team

Eligibility Criteria

Inclusion Criteria

Male or female patients 18 years of age or older

Patients undergoing surgery through an abdominal incision of at least 3 cm who are expected to be hospitalized for at least 36 hours and are expected to subsequently require at least 48 hours of oral opioid therapy.

Washout of at least 45 minutes for parenteral and 4 hours for IM analgesia.

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