Status:
COMPLETED
Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Acute Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
Following abdominal surgery and after sufficient washout from post-surgical analgesia, patients were randomized to one of the following four treatment groups; 1) oxymorphone IR 10 mg, 2) oxymorphone I...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00226395
Start Date
September 1 2004
End Date
August 1 2005
Last Update
January 2 2024
Active Locations (21)
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1
Brookwood Medical Center
Birmingham, Alabama, United States, 35205
2
The Medical Center, Dept. Clinical research
Birmingham, Alabama, United States, 35205
3
Montgomery Women's Health Associates
Montgomery, Alabama, United States, 36113
4
Arrowhead Community Hospital
Phoenix, Arizona, United States, 85023