Randomised, Double-blind, Double-dummy, Cross-over Multicenter Study to Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Taking Oxycodone Equivalents of 120 & 160 mg Per Day as Achieved With the Higher OXN PR Tablet Strengths (OXN60/30 mg PR, OXN80/40 mg PR) BID Compared to the Identical Daily Dose Taken as a Combination of Lower Tablet Strengths in Subjects With Non-malignant or Malignant Pain That Requires Around-the-clock Opioid Therapy.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 155
- Primary Endpoint
- Equivalent bowel function as assessed by the Bowel Function Index (BFI).
Study Overview
Brief Summary
This study is aimed to demonstrate equivalence between combinations of lower strength OXN PR tablets (OXN PR LST) and single higher strength OXN PR tablets (OXN PR HST) taken at the same overall daily dose.
Detailed Description
Study OXN3508 is a multicenter double-blind, double-dummy, randomised, cross-over, 2-period, phase III study in male and female subjects with severe non-malignant or malignant pain that requires around-the-clock opioid therapy at a daily dose of 120/60 mg or 160/80 mg oxycodone/naloxone prolonged release (OXN PR).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- 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
OXN PR HST
Prolonged release oxycodone/naloxone higher strength tablets
Intervention: Oxycodone (Drug)
OXN PR LST
Prolonged release oxycodone/naloxone lower strength tablets
Intervention: Naloxone (Drug)
Outcomes
Primary Outcomes
Equivalent bowel function as assessed by the Bowel Function Index (BFI).
Time Frame: Week 2, 3 5 and 6 from date of randomisation.
(mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale.)
Time Frame: 24 hours at one day in week 2, 3 5 and 6 from date of randomisation.
Pain scores based on the mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale. To demonstrate equivalence between multiple lower strength OXN PR tablets and a single higher strength OXN PR tablet taken at the same overall total daily dose
Secondary Outcomes
- Number of participants with adverse events, high/low laboratory values and clinically significant ECG findings.(Up to 35 weeks)
- Pain right now scores at intake of oxycodone/naloxone tablets.(Week 2,3,5 and 6 from date of randomisation)
- Pain scores of subjects average pain over the last 24 hours and rescue medication use.(Week 1,2,3,4,5 and 6 from date of randomisation)
- To assess quality of life based on the EuroQol EQ-5D.(Visit 3 and visit 6 from date of randomisation)
- To assess bowel function (assess BFI and laxative use)(Week 1,2,3,4,5 and 6 from date of randomisation)