CompletedPhase 2ACTRN12607000493448

A study comparing oxycodone to oxycodone/naloxone in moderate to severe, chronic cancer pain.

A randomised, double-blind, active-controlled, double-dummy, parallel group study to determine the safety and efficacy of oxycodone/naloxone prolonged release tablets in subjects with moderate to severe, chronic cancer pain.


Sponsor

Mundipharma Research GmbH & Co KG

Enrollment

180 participants

Start Date

Aug 27, 2007

Study Type

Interventional

Conditions

Summary

The aim of this clinical study is to determine how well a new prolonged release oxycodone/naloxone combination tablet works in reducing constipation whilst still giving the patient the required amount of pain relief in patients suffering from cancer pain.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study looks at a study comparing oxycodone to oxycodone/naloxone in moderate to severe, chronic cancer pain. It is open to both men and women aged 18 Years and older. Participants will be screened based on specific health criteria to see if they qualify. If you join, the research team will explain what is involved and monitor your health throughout the study.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Oxycodone/Naloxone prolonged release, 5/2.5, 10/5, 20/10, 40/20 mg oxycodone/naloxone combination, 12 hourly for 4 weeks, taken orally

Oxycodone/Naloxone prolonged release, 5/2.5, 10/5, 20/10, 40/20 mg oxycodone/naloxone combination, 12 hourly for 4 weeks, taken orally


Locations(8)

United Kingdom

Czech Republic

France

Hungary

Israel

Germany

Netherlands

Poland

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ACTRN12607000493448