NCT01885182

Determine the Safety and Efficacy of Oxy/Nal Tablets Compared to Oxy PR in Subjects With Cancer Pain

A Phase III, Randomized, Double-blind, Double-dummy, Parallel Group Study to Determine the Safety and Efficacy of Oxy/Nal Prolonged Release Tablets Compared to Oxy PR in Subjects With Moderate to Severe, Chronic Cancer Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To Determine the Safety and Efficacy of Oxycodone / Naloxone Prolonged Release Tablets compared to Oxycodone PR in Subjects with Moderate to Severe, Chronic Cancer Pain

Detailed description

This is a randomised, double-blind, double-dummy, parallel group study using OXN and OXY PR to treat moderate to severe, chronic cancer pain. Subjects with documented history of cancer pain that requires around the clock opioid therapy will be included. Subjects must have a medical history of constipation that was induced by, or worsened by their opioid therapy.

Conditions

• Cancer
• Pain

Interventions

Type	Name	Description
DRUG	Oxycodone/Naloxone
DRUG	Oxycodone

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-08-30
• Completion: 2015-12-30
• First posted: 2013-06-24
• Last updated: 2019-10-04
• Results posted: 2019-09-16

Locations

28 sites across 1 country: China