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

Completed · Phase 3

Conditions studied: Acute Pain

In brief

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.

Key facts

Study ID

NCT00226395

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

320

Starts

2004-09-01

Expected to finish

2005-08-01

Last updated by the study team

2024-01-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Initial pain intensity score of at least 50 mm on a 100-mm VAS and a categorical pain rating of moderate or severe on a scale of none, mild, moderate, or severe.
• Written informed consent.

You may not qualify if…

• Known allergy or significant reaction to opioids.
• History of chronic opioid use or opioid abuse within 6 months prior to study entry.
• History of alcohol or substance abuse within the last 3 years.
• Have been a participant in a study of an investigational drug or device within 30 days prior to study entry.
• Have been a previous participant in an oxymorphone clinical trial.
• Are currently taking or have taken a monoamine oxidase inhibitor (MAOI) drug within 2 weeks prior to study entry.
• Are currently taking or have taken St. John's Wort >1000 mg/day within 2 days prior to study entry.
• Use of long-acting oral and parenteral analgesics (opioid, non-opioid or non-steroidal anti-inflammatory drug [NSAID]) within 12 hours (at least 24 hours for cyclooxygenase-2 [COX 2] analgesics) prior to receiving study medication.
• Are not stabilized on the following medications for at least 4 weeks prior to dosing: tricyclic antidepressant drugs; serotonin reuptake inhibitors; amphetamines used for attention-deficit hyperactivity disorder (ADHD)
• Have a history of seizure.

Where it is running

• Brookwood Medical Center — Birmingham, Alabama, United States
• The Medical Center, Dept. Clinical research — Birmingham, Alabama, United States
• Montgomery Women's Health Associates — Montgomery, Alabama, United States
• Arrowhead Community Hospital — Phoenix, Arizona, United States
• John C Lincoln Hospital — Phoenix, Arizona, United States
• Paradise Valley Hospital — Phoenix, Arizona, United States
• Glendale Adventist Medical Center — Glendale, California, United States
• Saddleback Memorial Medical Center — Laguna Hills, California, United States
• Huntington Memorial Hospital — Pasadena, California, United States
• Palm West Hospital — Palm Springs, Florida, United States
• Sacred Heart Hospital — Pensacola, Florida, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Forsyth Medical Center — Winston-Salem, North Carolina, United States
• Medical Park Hospital — Winston-Salem, North Carolina, United States
• Univ. Pittsburgh Hospital — Pittsburgh, Pennsylvania, United States
• Univ. Pittsburgh Medical center — Pittsburgh, Pennsylvania, United States
• Memorial Hermann Memorial City Hospital — Houston, Texas, United States
• The Methodist Hospital — Houston, Texas, United States
• Cottonwood Hospital — Salt Lake City, Utah, United States
• LDS Hospital — Salt Lake City, Utah, United States
• McKay-Dee Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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