NCT01438567

A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Mundipharma Research GmbH & Co KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary research objective is to demonstrate that subjects taking OXN PR have improvement in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to subjects taking OxyPR tablets alone with cancer and non-cancer related pain without reducing the effectiveness of pain relief as measured by the Brief Pain Inventory (BPI).

Detailed description

The study OXN3506 is a multicentre, multiple-dose, randomised, double-blind, double-dummy, active-controlled, parallel-group study in male and female subjects with non-malignant or malignant pain requiring opioids to assess analgesic efficacy and symptoms of constipation secondary to opioid treatment. Subjects will be randomised to two treatment groups and will be treated with OXN PR or OxyPR for up to 5 weeks. The study is composed of three phases, a pre-randomisation phase, a double-blind phase and an extension phase.

Conditions

• Pain
• Constipation

Interventions

Type	Name	Description
DRUG	oxycodone/naloxone prolonged release (OXN PR) tablets	Drug: Oxycodone/naloxone prolonged release tablets Arms: OXN PR Dosage: 2x50/25mg daily or 2x60/30mg daily or 2x70/35mg daily or 2x80/40mg daily
DRUG	oxycodone prolonged release (OxyPR) tablets	Drug: Oxycodone prolonged release tablets Arms: OxyPR Dosage: 2x50mg daily or 2x60mg daily or 2x70mg daily or 2x80mg daily

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-02-01
• Completion: 2014-09-01
• First posted: 2011-09-22
• Last updated: 2018-10-23

Locations

1 site across 1 country: United Kingdom