NCT00412152

Oxycodone-naloxone in Relieving Opioid-related Constipation

A Randomised, Double-blind, Parallel-group, Multicentre Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Non-malignant Pain Taking Oxycodone Equivalent of >20 mg/Day and <50 mg/Day as Oxycodone/Naloxone Prolonged Release Compared to Subjects Taking Oxycodone Prolonged Release Tablets Alone.

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

Summary

The primary objective of this study is to demonstrate that subjects with moderate to severe non-malignant pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

Detailed description

Patients with a documented history of moderate to severe non-malignant pain that require around the clock opioid therapy will be randomised to an oxycodone or an oxycodone-naloxone treatment arm to assess the safety and efficacy of oxycodone/naloxone prolonged release compared to oxycodone prolonged-release in relieving opioid-related constipation.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Oxycodone nalaxone prolonged release tablets (OXN)

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-04-01
• Completion: 2008-06-01
• First posted: 2006-12-15
• Last updated: 2018-10-23