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This non-interventional, observational study evaluates the efficacy of Targinact with regard to pain relief in daily clinical practice in Belgium compared to the previous analgesic treatment.
Patients are treated with Targinact® according to daily clinical practice and are monitored during 3 study visits. Parameters assessed are efficacy regarding pain relief, efficacy regarding bowel function, pain relief, use of analgesic rescue medication, bowel function, use of laxatives, safety of Targinact treatment, use of concomitant medication, patient satisfaction and quality of life.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targinact® (oxycodone/naloxone) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of Targinact® treatment, with regard to pain relief, in patients with severe pain | Efficacy will be evaluated by the physician (7 categories). For the analysis the ordinal scale will be reduced to a binary scale: responder or non-responder. A responder is defined as a patient responding ''slightly better'', ''better'' or ''much better'' at any time during the Targinact®therapy. A non-responder is defined as a patient responding "same", "slightly worse", "worse", "much worse". | Up to 140 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain NAS score (0-10) will be measured at each visit | The relative changes from baseline at each visit will be used to compare the NAS pain scores during the Targinact® therapy. | Up to 140 days |
| Bowel Function Index (BFI) will be recorded at each visit |
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Inclusion criteria:
Patients who are to be included in the study, are those who meet all of the following criteria based on the SPC.
Exclusion criteria are based on the SPC of Targinact®.
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GPs and specialists
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp (UZA): | Antwerp | Belgium |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059350 | Chronic 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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The Bowel Function Index is the mean value of the 3 single items included in the BFI:1/ Difficulty of bowel movement (0 to 100; 0 = easy/no difficulty, 100 = severe difficulty); 2/ Feeling of incomplete bowel evacuation (0 to 100; 0 = not at all, 100 = very strong); 3/ Judgement of constipation (0 to 100; 0 = not at all, 100 = very strong). |
| Up to 140 days |
| The use of laxative medication (yes/no) per 24 hours will be recorded in the e-CRF | If laxative is used, the physician will document if it's used 1/ continuously, 2/ intermittently or 3/ rarely. | Up to 140 days |
| The use of analgesic rescue medication (yes/no) used per day (24 hours) will be recorded | Up to 140 days |
| Efficacy of Targinact® treatment, with regard to bowel function, will be evaluated by the physician (7 categories) | For the analysis the ordinal scale will be reduced to a binary scale: responder or non-responder. A responder is defined as a patient responding ''slightly better'', ''better'' or ''much better'' at any time during the Targinact® therapy. A non-responder is defined as a patient responding "same", "slightly worse", "worse", "much worse". | Up to 140 days |
| The patient satisfaction will be evaluated by patient in 7 categories | much worse, worse, slightly worse, same, slightly better, better, much better. | Up to 140 days |
| The patient's quality of life will be evaluated via the EQ-5D questionnaire | Up to 140 days |
| 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 |