Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain
NCT ID: NCT00226395
Last Updated: 2024-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
320 participants
INTERVENTIONAL
2004-09-30
2005-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Oxymorphone immediate release
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Locations
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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
Countries
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Other Identifiers
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EN3203-009
Identifier Type: -
Identifier Source: org_study_id
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