To Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Between OXN PR Higher Dose & Lower Dose Tablet Strengths in Subjects With Non-cancer or Cancer Pain

Study Overview
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Brief Summary
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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
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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).

Official Title
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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.

Conditions
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Malignant Pain, Non-malignant Pain

Intervention / Treatment
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* Drug: Oxycodone
* Drug: Naloxone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subjects who are receiving WHO step III opioid analgesic medication for the treatment of non-malignant or malignant pain. Documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy Exclusion Criteria Females who are pregnant or lactating. Subjects with evidence or significant structural abnormalities of the gastrointestinal tract. Subjects with evidence of impaired liver/kidney function upon entry into the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OXN PR HST<br>Prolonged release oxycodone/naloxone higher strength tablets | Drug: Oxycodone<br> <br> |
| Active Comparator: OXN PR LST<br>Prolonged release oxycodone/naloxone lower strength tablets | Drug: Naloxone<br>* Prolonged Release Tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale.) | 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 | 24 hours at one day in week 2, 3 5 and 6 from date of randomisation. | 
| Equivalent bowel function as assessed by the Bowel Function Index (BFI). |  | Week 2, 3 5 and 6 from date of randomisation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 bowel function (assess BFI and laxative use) | To assess BFI and laxative use | Week 1,2,3,4,5 and 6 from date of randomisation | 
| To assess quality of life based on the EuroQol EQ-5D. | EuroQol EQ-5D is a standardized instrument for use as a measure of health outcome. | Visit 3 and visit 6 from date of randomisation | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxycodone naloxone combination, severe chronic and non-malignant pain, Malignant and non-malignant pain that requires around-the clock opioid therapy