Post-operative Efficacy and Safety Study

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Endo Pharmaceuticals
• Treatments: Oxymorphone

Criteria

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