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This non-interventional, observational study is set up on request of the Belgian reimbursement authorities and evaluates the efficacy of Targinact with regard to pain relief and constipation in daily clinical practice in Belgium compared to the previous analgesic treatment with prolonged release oxycodone. Only patients eligible for Targinact® reimbursement in Belgium are included.
Patients are treated with Targinact® according to daily clinical practice during at least 12 weeks and are monitored during study 3 visits. Parameters assessed are pain relief, constipation, use of laxatives, use of analgesic rescue medication, use of concomitant medication, quality of life and safety of Targinact® treatment. These parameters, except for safety assessment, are compared between Targinact® treatment and previous analgesic treatment with prolonged release oxycodone.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targinact® (oxycodone/naloxone) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of responders after Targinact treatment compared to the previous treatment with prolonged release oxycodone. | A responder is defined as a patient who shows no worsening of pain (pain score has increased ≤ 1 unit on a 11-points pain NRS) at V3/the last visit compared to V1 or has a NRS ≤4 on a 11-points pain NRS at V3/the last visit AND has a reduction in BFI ≥ 12 units at V3/the last visit compared to V1 or has a BFI ≤30 at V3/ the last visit. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To assess laxative use during Targinact® treatment compared to previous PR oxycodone treatment (by physician) | To assess laxative use during Targinact® treatment compared to previous PR oxycodone treatment (by physician) | 12 weeks |
| To assess the use of analgesic rescue medication during Targinact® treatment compared to previous PR oxycodone treatment (by physician) |
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Inclusion criteria: patients included are patients who
Exclusion criteria are based on Targinact® SPC.
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Primary and Secondary Care
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Brussels | Brussels | Belgium |
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| Label | URL |
|---|---|
| Clinical Therapeutics | View source |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010146 | Pain |
| D000079689 | Opioid-Induced Constipation |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003248 | Constipation |
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| ID | Term |
|---|---|
| C557247 | oxycodone naloxone combination |
| D010098 | Oxycodone |
| D009270 | Naloxone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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To assess the use of analgesic rescue medication during Targinact® treatment compared to previous PR oxycodone treatment (by physician) |
| 12 weeks |
| To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous PR oxycodone treatment (by patient) | To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous PR oxycodone treatment (by patient) | 12 weeks |
| To assess safety of Targinact® treatment (by physician) | Safety will be assessed by documentation of adverse events, collected via spontaneous reports and patient documentation. | 12 weeks |
| D012817 | Signs and Symptoms, Digestive |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| 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 |