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.
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 IR 20 mg, 3) oxycodone IR 15 mg, or 4) placebo. Total duration of treatment was 48 hours. Patients were required to take the study medication every 4-6 hours. After the first dose, periodic pain assessments were performed for the first six hours. Subsequently, patients were required to assess their current pain intensity and average pain intensity since the last dose of study medication just prior to every dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
320
Brookwood Medical Center
Birmingham, Alabama, United States
Time to discontinuation due to all causes
The following are the secondary endpoints during the initial 6 hours following the first dose of study medication:
- 6-Hour Sum of Pain Intensity Differences (SPID; VAS and categorical)
- 6-Hour Total Pain Relief Scores (TOTPAR; VAS and categorical)
- Time (in hours) to First Perceptible Pain Relief
- Time (in hours) to Meaningful Pain Relief
- Hourly Pain Relief Scores
- Hourly Pain Intensity Difference Scores
The following are the secondary endpoints during the multiple dosing phase:
- Mean average pain intensity scores collected during the dosing intervals.
- Mean current pain intensity (VAS) collected during the dosing intervals.
- Patient's global evaluation of study medication at the end of study.
- Physician's global evaluation of study medication at the end of study.
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The Medical Center, Dept. Clinical research
Birmingham, Alabama, United States
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