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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004888-31 | EudraCT Number |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OXN PR HST | Experimental | Prolonged release oxycodone/naloxone higher strength tablets |
|
| OXN PR LST | Active Comparator | Prolonged release oxycodone/naloxone lower strength tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug |
| ||
| Naloxone |
| 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. |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mainz | Germany |
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Prolonged Release Tablets |
|
| 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 |
| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D009270 | Naloxone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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