Status:
COMPLETED
Post-operative Efficacy and Safety Study
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Post-operative Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00904085
Start Date
April 1 2003
End Date
June 1 2003
Last Update
February 15 2010
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