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

Study Overview
=================
Brief Summary
-----------------
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.

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 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.

Official Title
-----------------
The Evaluation of Targinact® in Daily Practice, With Regards to Pain Relief and Constipation, in Chronic Severe Pain Patients Compared to Previous Prolonged Release Oxycodone Treatment: a Non-interventional, Observational Study.

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: patients included are patients who are eligible for Targinact® treatment according to the Targinact® SPC AND who have previously been treated with PR oxycodone during at least the last 30 days before study inclusion AND who are constipated (BFI > 30) AND have used at least 2 laxatives with different modes of action during the previous PR oxycodone treatment Exclusion criteria are based on 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

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

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

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

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