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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2006-006579-19 |
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The purpose of the study is to determine the effect of Egalet® Morphine once daily compared to MST Continus twice daily on pain intensity and use of rescue medication for break through pain after 2 weeks of treatment in patients with pain due to cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Egalet® morphine | Experimental |
| |
| MST Continus® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine Sulphate | Drug | Egalet® morphine, Controlled Release 30 mg Oral tablet once daily for 2 weeks and MST Continus® 15 mg twice daily for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Use of rescue medication | 2 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | 2 weeks treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Andersen, MSc Pharm | Egalet A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 51 | Kaunas | Lithuania | ||||
| Site 50 |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Vilnius |
| Lithuania |
| Site 63 | Bielsko-Biaia | Poland |
| Site 60 | Bydgoszcz | Poland |
| Site 62 | Poznan | Poland |
| Site 61 | Warsaw | Poland |
| Site 64 | Wroclaw | Poland |
| Site 65 | Włocławek | Poland |
| 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 |