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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 232
- Locations
- 28
- Primary Endpoint
- The Change of BPI-SF at visit8
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Oxycodone
5mg, 10mg, 20mg or 40mg
Intervention: Oxycodone (Drug)
Oxycodone/Naloxone
5/2.5mg, 10/5mg, 20/10mg or 40/20mg
Intervention: Oxycodone/Naloxone (Drug)
Outcomes
Primary Outcomes
The Change of BPI-SF at visit8
Time Frame: Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from study
Brief pain inventory short-form(BPI-SF) recorded at final visit assesses subject's average pain over the last 24 hours. score range is 0(no pain)-10(pain as bad as you can imagine).Do higher values represent a worse outcome.
The Change of BFI-Bowel Function Index at visit8
Time Frame: Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from study
BFI is the mean of NAS for the following items: * Ease of defecation * Feeling of incomplete bowel evacuation. * Personal judgment of constipation. NAS was a measure of 0-100 where 0 was easy/no difficulty/not at all and 100 was severe difficulty/very strong,total score range is 0-300.Do higher values represent a worse outcome.
Secondary Outcomes
- The Change of Symptoms of Constipation Based on Laxative Use From visit5 to visit8(visit 5 (week 1) to visit8 (week 4 or early discontinue/withdrawal from study))
- The Change of Rescue Medication Use From visit5 to visit8(visit 5 (week 1) to visit8 (week 4 or early discontinue/withdrawal from study))
- The Change of Modified Subjective Opiate Withdrawal Scale (SOWS) From Visit1 to visit3,visit1 to visit9(Visit1(screening visit) to visit3 (day 1), visit1(screening visit) to visit9 (week 5))
- To Assess Quality of Life Based on EQ-5D(Visit1(screening visit) to Visit8 (week 4 or after early discontinuation/withdrawal from study))
- The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit(visit2 (day 0) to visit8 (week 4 or early discontinue/withdrawal from study))
- The Change of Bowel Movement by Visit(visit2 (day 0) to visit8 (week 4 or early discontinue/withdrawal from study))
- The Chage of Symptoms of Constipation Based on Laxative Use From visit5 to visit8(visit 5 taking place at week 1 to visit8 taking place at week 4 or early discontinue/withdrawal from study where applicable)