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

NCT00831051 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 197

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 and Q8003 6 mg/4 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute moderate to severe postoperative pain following bunionectomy surgery.

Conditions

  • Postoperative Pain

Interventions

DRUG

Q8003

One Q8003 (morphine sulfate and oxycodone HCl) 12mg/8mg IR Capsule q6h

DRUG

Morphine sulfate

One morphine sulfate 12mg IR capsule q6h

DRUG

Oxycodone HCl

One oxycodone HCl 8mg IR Capsule q6h

DRUG

Q8003

One Q8003 (morphine sulfate and oxycodone HCl) 6mg/4mg IR Capsule q6h

DRUG

Morphine sulfate

Two morphine sulfate 3mg IR capsules q6h

DRUG

Oxycodone HCl 4mg

Two oxycodone HCl 2mg IR Capsules 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
2008-12-31
Primary Completion
2009-01-31
Completion
2009-02-28

Countries

  • United States

Study Locations

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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 NCT00831051 on ClinicalTrials.gov