A Study Comparing Oxycodone to Oxycodone/Naloxone in Moderate to Severe, Chronic Cancer Pain
The purpose of this study is to test the oxycodone/naloxone combination compared to oxycodone alone in patient's specific type of "chronic cancer pain".
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomised, Double-blind, Active-controlled, Double-dummy, Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Subjects With Moderate to Severe, Chronic Cancer Pain|
- Efficacy variable: Bowel Function Index (BFI) score. Amount of laxative medication use recorded at each assessment visit [ Time Frame: 4 weeks and a 6 month open label ] [ Designated as safety issue: No ]
- Efficacy variable: Brief Pain Inventory Short-Form (BPI-SF) (Cleeland, 1991). Amount of analgesic rescue medication used [ Time Frame: 4 weeks and a 6 month open label ]
- Number of bowel movements
- Modified Subjective Opiate Withdrawal Scale (SOWS)
- EuroQol EQ-5D
- EORTC QLQ-C30
|Study Start Date:||September 2007|
|Study Completion Date:||June 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: Oxycodone Hydrochloride Tablets||Drug: Oxycodone|
|Experimental: Oxycodone Naloxone Tablets||Drug: Oxycodone/Naloxone|
This is a randomised, double-blind, active-controlled, double-dummy, parallel group study using oxycodone/naloxone and oxycodone 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.
After subjects have qualified for the study they will be randomised and to enter the double-blind treatment phase of the study.
Subjects will be randomised to receive either oxycodone/naloxone or oxycodone. Subjects will receive the double-blind medication for a period of 4 weeks.
Subjects who complete the double-blind phase or who discontinue due to constipation and still comply with all relevant screening inclusion and exclusion criteria will have the option to enter the 24 week extension phase. Subjects will receive open-label oxycodone/naloxone for up to 24 weeks.