Pain Clinical Trial
Official title:
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
The purpose of this study is to test the oxycodone/naloxone combination compared to oxycodone alone in patient's specific type of "chronic cancer pain".
This is a randomised, double-blind, active-controlled, double-dummy, parallel group study
using oxycodone/naloxone and oxycodone to treat moderate to severe, chronic cancer pain.
Subjects with documented history of cancer pain that requires around-the-clock opioid therapy
will be included. Subjects must have a medical history of constipation that was induced by,
or worsened by their opioid therapy.
After subjects have qualified for the study they will be randomised and to enter the
double-blind treatment phase of the study.
Subjects will be randomised to receive either oxycodone/naloxone or oxycodone. Subjects will
receive the double-blind medication for a period of 4 weeks.
Subjects who complete the double-blind phase or who discontinue due to constipation and still
comply with all relevant screening inclusion and exclusion criteria will have the option to
enter the 24 week extension phase. Subjects will receive open-label oxycodone/naloxone for up
to 24 weeks.
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