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
Who is eligible to participate?
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Oxycodone/Naloxone5/2.5mg, 10/5mg, 20/10mg or 40/20mg
Oxycodone5mg, 10mg, 20mg or 40mg
Start Date: June 1, 2013
Completed Date: December 30, 2015
Phase: Phase 3
Primary Outcome: BFI-Bowel Function Index
Secondary Outcome: BPI-Brief Pain Index
Study sponsors, principal investigator, and references
Principal Investigator: Victoria Yu
Lead Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd