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Pilot Study of the Efficacy and Safety of Q8003 in Patients Who Have Undergone Total Knee Arthroplasty or Total Hip Arthroplasty

NCT00818493 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2012-05-17

No results posted yet for this study

Summary

This is a Phase 2 3-arm, open label pilot study of the safety and efficacy of Q8003 in patients who have undergone primary unilateral total knee arthroplasty or total hip arthroplasty.

Conditions

  • Postoperative Pain

Interventions

DRUG

Q8003 (morphine sulfate and oxycodone hydrochloride)

IR Capsules, ascending flexible dose, every 4 to 6 hours

DRUG

Low dose Q8003 (morphine sulfate and oxycodone hydrochloride)

One 3mg/2mg or 6mg/4mg IR Capsule every 4 to 6 hours

DRUG

Percocet (oxycodone and acetaminophen)

One or two 5mg/325 mg tablets every 4 to 6 hours

Sponsors & Collaborators

  • QRxPharma Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-07-31
Completion
2009-07-31

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 NCT00818493 on ClinicalTrials.gov