MedTrace Logo

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

NCT01016808 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 522

Last updated 2012-05-17

No results posted yet for this study

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.

Conditions

  • Moderate to Severe Postoperative Pain

Interventions

DRUG

Q8003

Q8003 is a combination of morphine sulfate and oxycodone HCl

DRUG

Morphine sulfate

One morphine sulfate 12 mg IR capsule q6h

DRUG

Oxycodone HCl

One oxycodone HCl 8 mg IR Capsule q6h

Sponsors & Collaborators

  • QRxPharma Inc.

    lead INDUSTRY

Principal Investigators

  • Patricia T. Richards, MD, Ph.D. · QRxPharma Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01016808 on ClinicalTrials.gov