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Comparison of the Safety of Q8003 Versus Morphine Equivalent Doses of Its Components (Oxycodone and Morphine) in Bunionectomy Patients

NCT01280331 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2012-05-17

No results posted yet for this study

Summary

This is a randomized, double-blind, multicenter, repeat-dose study of fixed doses of Q8003 12 mg/8 mg given q6hr compared to morphine sulfate 24 mg and oxycodone hydrochloride 16 mg given q6hr for the management of acute moderate to severe postoperative pain for 48 hours following bunionectomy surgery.

Conditions

  • Postoperative Pain

Interventions

DRUG

Q8003 (morphine sulfate and oxycodone hydrochloride)

Two Q8003 6 mg/4 mg IR Capsules q6h

DRUG

Morphine sulfate

Two morphine sulfate 12 mg IR capsules q6h

DRUG

Oxycodone HCl

Two oxycodone HCl 8 mg 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
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-04-30
Completion
2011-04-30

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 NCT01280331 on ClinicalTrials.gov