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Efficacy and Safety of Q8003 in the Management of Post-bunionectomy Pain

NCT00560183 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2012-05-17

No results posted yet for this study

Summary

This study will explore the efficacy and safety of a fixed dose combination of morphine and oxycodone for management of acute postoperative pain. The study will explore the efficacy dose response and dosing interval required to maintain adequate analgesia at each tested dosage strength.

Conditions

  • Postoperative Pain

Interventions

DRUG

Q8003 (morphine sulfate and oxycodone hydrochloride)

Capsules, four different mg dosage strengths

DRUG

Placebo

Capsules

Sponsors & Collaborators

  • QRxPharma Inc.

    lead INDUSTRY

Principal Investigators

  • Warren Stern, 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
2007-11-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00560183 on ClinicalTrials.gov