A Non-interventional, Observational Study for Quality of Life (Overall Health Assessment) in Patients With Chronic Severe Pain During Targinact® Treatment

Study Overview
=================
Brief Summary
-----------------
This non-interventional, observational study evaluates the efficacy of Targinact with regard to quality of life in daily clinical practice in Belgium compared to the previous analgesic treatment.

Detailed Description
-----------------
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 overall health assessment of the patient, 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.

Official Title
-----------------
The Efficacy of Targinact® Treatment With Respect to Quality of Life (Overall Health Assessment) in Chronic Severe Pain Patients Compared to Previous Analgesic Treatment: a Non-interventional, Observational Study.

Conditions
-----------------
Chronic Severe Pain

Intervention / Treatment
-----------------
* Drug: Targinact® (oxycodon/naloxon)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients enrolled in the study are patients who are eligible for Targinact® treatment according to the Targinact® SPC AND who have previously been treated with WHO step 1, 2 or 3 analgesics Exclusion criteria are based on the Targinact® SPC.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Targinact® (oxycodon/naloxon)<br> | Drug: Targinact® (oxycodon/naloxon)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of Targinact® treatment | The primary parameter to assess the efficacy of Targinact® treatment with respect to the quality of life (overall health assessment/EQ-VAS) in patients with chronic severe pain compared to previous analgesic treatment is the absolute change in overall health score (0-100) attributed by patients during Targinact® treatment compared to previous analgesic treatment. During each visit, patients will be asked to score their overall health state between 0 (worst health state imaginable) and 100 (best health state imaginable). The absolute changes in overall health assessment from baseline at V2 and V3 will be used to compare health assessment during Targinact® treatment. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician) | To assess pain (NRS) during Targinact® treatment compared to previous analgesic treatment (by physician) | 12 weeks | 
| To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician) | To assess constipation (BFI) during Targinact® treatment compared to previous analgesic treatment (by physician) | 12 weeks | 
| To assess laxative use during Targinact® treatment compared to previous analgesic treatment (by physician) | To assess laxative use during Targinact® treatment compared to previous analgesic treatment (by physician) | 12 weeks | 
| To assess the use of analgesic rescue medication during Targinact® treatment compared to previous analgesic treatment (by physician) | To assess the use of analgesic rescue medication during Targinact® treatment compared to previous analgesic treatment (by physician) | 12 weeks | 
| To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous analgesic treatment (by patient) | To evaluate the quality of life (EQ-5D questionnaire) during Targinact® treatment compared to previous analgesic 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic pain, Severe pain, Oxycodon, Naloxon, Opioid-induced constipation, Opioid, Quality of life, Laxative, Analgesic rescue medication