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An exploratory, randomised, active-controlled, double-blind, double-dummy, parallel group pilot study to determine the ability of oxycodone/naloxone prolonged release tablets (OXN) to reduce the number of subjects developing symptoms of opioid induced constipation compared to morphine prolonged release tablets (MOR PR) in opioid naive, non-constipated subjects with non malignant pain that require opioid treatment.

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Trial Profile

An exploratory, randomised, active-controlled, double-blind, double-dummy, parallel group pilot study to determine the ability of oxycodone/naloxone prolonged release tablets (OXN) to reduce the number of subjects developing symptoms of opioid induced constipation compared to morphine prolonged release tablets (MOR PR) in opioid naive, non-constipated subjects with non malignant pain that require opioid treatment.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 25 Jul 2019

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At a glance

  • Drugs Naloxone/oxycodone (Primary) ; Morphine
  • Indications Constipation
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Mundipharma GmbH

Most Recent Events

  • 25 Jul 2019 Status changed from recruiting to completed.
  • 20 Jun 2012 Actual initiation date changed from 30 Mar 2009 to 22 May 2008 as reported by European Clinical Trials Database.
  • 20 Jun 2012 Planned end date changed from 30 Sep 2010 to 22 Nov 2009 as reported by European Clinical Trials Database.

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