Post-operative Efficacy and Safety Study
Status and phase
Completed
Phase 3
Conditions
Post-operative Pain
Treatments
Drug: Oxymorphone IR
Details and patient eligibility
About
The purpose of this study was to compare the analgesic efficacy of 5 mg oxymorphone IR with placebo in patients with mild to moderate pain following outpatient knee arthroscopy.
Enrollment
122 patients
Sex
All
Ages
18+ years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Males or females, 18 years of age or older, who have completed outpatient knee arthroscopy
- Have an initial pain intensity score of between 30mm and 70mm on a 100mm Visual Analogue Scale(VAS) and a categorical pain rating scale of none, mild, moderate, or severe,
- Have been informed of the nature of the study and provided written informed consent
Exclusion criteria
- Have a positive pregnancy test
- Have received any of the following medications within 24 hours prior to dosing: COX2 inhibitors, Minor Tranquilizers, Muscle relaxants, Antihistamines
- Long-acting oral and parenteral analgesics are prohibited for at least 12 hours prior to receiving study medication.
- Have received any of the following medication within 48 hours prior to dosing: Chronic use of analgesics (opioid or non-opioid including aspirin [>325 mg/day], acetaminophen, and NSAIDs)
- Have received MAOI drugs within 2 weeks prior to dosing
- Not stabilized on the following medications for at least 4 weeks prior to dosing: Tricyclic antidepressant drugs, Serotonin reuptake inhibitors, Amphetamines used for ADHD
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Single Group Assignment
Masking
Double Blind
122 participants in 2 patient groups, including a placebo group
Oxymorphone
Active Comparator group
Treatment:
Drug: Oxymorphone IR
Placebo
Placebo Comparator group
Treatment:
Drug: Oxymorphone IR
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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