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.
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
- 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.