A Randomized, Double-blind, Double-dummy, Parallel-group, Multicenter Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Moderate to Severe Non-malignant Pain Taking Oxycodone Equivalent of ≥10 mg/Day and ≤50 mg/Day as Oxycodone/Naloxone Prolonged-release (OXN) Compared to Subjects Taking Oxycodone Prolonged-release (OXY) Tablets Alone.

Trial Profile

A Randomized, Double-blind, Double-dummy, Parallel-group, Multicenter Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Moderate to Severe Non-malignant Pain Taking Oxycodone Equivalent of ≥10 mg/Day and ≤50 mg/Day as Oxycodone/Naloxone Prolonged-release (OXN) Compared to Subjects Taking Oxycodone Prolonged-release (OXY) Tablets Alone.

Recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Aug 2016

At a glance

  • Drugs Oxycodone/naloxone (Primary) ; Oxycodone
  • Indications Constipation; Musculoskeletal pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Mundipharma International
  • Most Recent Events

    • 29 Mar 2016 Planned number of patients changed from 270 to 230, according to ClinicalTrials.gov record.
    • 29 Mar 2016 Planned End Date changed from 1 Jun 2016 to 1 Sep 2016, according to ClinicalTrials.gov record.
    • 29 Mar 2016 Planned primary completion date changed from 1 Jun 2016 to 1 Sep 2016, according to ClinicalTrials.gov record.
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