Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients

Moderate to Severe Postoperative Pain Clinical Trial

Official title: A Randomized, Double-Blind, Multi-Center, Repeat-Dose, Comparison of the Analgesic Efficacy and Safety of Q8003 With Oxycodone and Morphine for the Management of Acute Moderate to Severe Postoperative Pain Following Bunionectomy Surgery

Status Completed

Clinical Trial Summary

This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute moderate to severe postoperative pain following bunionectomy surgery.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Moderate to Severe Postoperative Pain
• Pain, Postoperative

• NCT number: NCT01016808
• Study type: Interventional
• Source: QRxPharma Inc.
• Status: Completed
• Phase: Phase 3
• Start date: December 2009
• Completion date: March 2010