Post-operative Efficacy and Safety Study

Post-operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904085
• Other study ID #: EN3203-008
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2009
• Last updated: February 12, 2010
• Start date: April 2003
• Est. completion date: June 2003

Study information

• Verified date: February 2010
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• Oxymorphone IR
5 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of Pain Intensity (SPID) Visual Analog Scale (VAS)		2 months	No