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Clinical trial

A Randomised, Double-blind, Double-dummy, Parallel-group Multicenter Study to Demonstrate Improvement in Symptoms of Constipation and Non-inferiority in Analgesic Efficacy in Subjects With Non-malignant or Malignant Pain That Require Around-the-clock Opioid Therapy Taking 50/25 - 80/40 mg Twice Daily as Oxycodone/Naloxone Prolonged Release (OXN PR) Tablets Compared to Subjects Taking 50 - 80 mg Twice Daily Oxycodone Prolonged Release (OxyPR) Tablets Alone

NCT01438567 is registered in ClinicalTrials.gov with Mundipharma Research GmbH & Co KG as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomised, Double-blind, Double-dummy, Parallel-group Multicenter Study to Demonstrate Improvement in Symptoms of Constipation and Non-inferiority in Analgesic Efficacy in Subjects With Non-malignant or Malignant Pain That Require Around-the-clock Opioid Therapy Taking 50/25 - 80/40 mg Twice Daily as Oxycodone/Naloxone Prolonged Release (OXN PR) Tablets Compared to Subjects Taking 50 - 80 mg Twice Daily Oxycodone Prolonged Release (OxyPR) Tablets Alone
Lead sponsor
Mundipharma Research GmbH & Co KG
Phase
Phase 3
Overall status
Completed
Start date
September 30, 2011
Completion date
September 30, 2014
Enrollment
270 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.