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Double Blind Efficacy and Safety Study of Flexible-Dose vs Low-Dose Q8003 After Undergoing Primary Unilateral Total Knee Arthroplasty

NCT01055015 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2012-05-17

No results posted yet for this study

Summary

This is a Phase 3, two-arm, double-blind study of efficacy and safety of Q8003 in patients who have undergone primary unilateral total knee arthroplasty

Conditions

  • Postoperative Pain

Interventions

DRUG

Flexible dose Q8003 (morphine sulfate and oxycodone hydrochloride)

IR Capsules, flexible dose, every 4 to 6 hours

DRUG

Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)

One 3 mg/2 mg IR Capsule every 4 to 6 hours following a 6 mg/4 mg loading dose.

Sponsors & Collaborators

  • QRxPharma Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-12-31
Completion
2010-12-31

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 NCT01055015 on ClinicalTrials.gov