A Non-interventional, Observational Study for Targinact® Treatment in Patients With Severe Pain.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Efficacy, With Regard to Pain Relief, of Targinact® Treatment for Patients With Severe Pain Compared to Previous Analgesic Treatment; a Non-interventional Study.

Conditions
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Severe Pain

Intervention / Treatment
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* Drug: Targinact® (oxycodone/naloxone)


Participation Criteria
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Eligibility Criteria
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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. Male or female patients at least 18 years, or older, with severe pain. Patients with documented history of severe pain treated with WHO step 1, step 2 and/or 3 analgesics with insufficient pain relief and/or unacceptable side effects that require around-the-clock opioid therapy and are likely to benefit from WHO step 3 opioid therapy for the duration of the study. Exclusion criteria are based on the SPC of Targinact®.

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Targinact® (oxycodone/naloxone)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, Severe pain, oxycodon, naloxon, opioid-induced constipation, opioid, quality of life, laxative, analgesic rescue medication