Post-operative Efficacy and Safety Study
- Registration Number
- NCT00904085
- Lead Sponsor
- Endo Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Oxymorphone Oxymorphone IR - Placebo Oxymorphone IR -
- Primary Outcome Measures
Name Time Method Sum of Pain Intensity (SPID) Visual Analog Scale (VAS) 2 months
- Secondary Outcome Measures
Name Time Method