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A Study to Compare Oxycodone/Naloxone Prolonged Release Against Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis

NCT00784810 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2011-11-02

Study results available
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Summary

The purpose of this study is to compare oxycodone/naloxone combination tablet and codeine/paracetamol tablets in the treatment of moderate to severe chronic low back pain or pain due to osteoarthritis.

Conditions

Interventions

DRUG

Oxycodone/Naloxone

5/2.5, 10/5 and 20/10 mg oxycodone/naloxone combination, 12 hourly

DRUG

Codeine/Paracetamol

15/500 and 30/500 mg codeine/paracetamol tablets, 2 tablets 6 hourly

Sponsors & Collaborators

  • Napp Pharmaceuticals Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-03-31
Completion
2011-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00784810 on ClinicalTrials.gov