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Extension Study to Evaluate the Safety of Q8003 in Patients With Acute Moderate to Severe Pain

NCT00565760 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2012-05-17

No results posted yet for this study

Summary

This is a Phase 3 double-blind, multiple dose safety extension study of Q8003 administered at daily doses up to 36 mg morphine/24 mg oxycodone (Q8003 36mg/24mg) over a treatment period of up to 4 weeks. Patients with acute moderate to severe pain who have completed participation in one of the designated QRxPharma, Inc. acute pain lead-in studies will be eligible for this trial.

Conditions

  • Acute Moderate to Severe Pain

Interventions

DRUG

Q8003

Capsules

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
2008-03-31
Completion
2008-03-31

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 NCT00565760 on ClinicalTrials.gov