A Randomized, Double-blind Evaluation of the Analgesic Efficacy and Safety of a Low Dose Oxymorphone Immediate Release in Patients Following Ambulatory Arthroscopic Knee Surgery

Endo Pharmaceuticals0 sites122 target enrollmentApril 2003

ConditionsPost-operative Pain

InterventionsOxymorphone IR

DrugsOxymorphone IR

Overview

Phase: Phase 3
Intervention: Oxymorphone IR
Conditions: Post-operative Pain
Sponsor: Endo Pharmaceuticals
Enrollment: 122
Primary Endpoint: Sum of Pain Intensity (SPID) Visual Analog Scale (VAS)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2003

End Date

June 2003

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Endo Pharmaceuticals

Eligibility 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