taPentadol cLinical prAcTice IN belgiUM

Study Overview
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Brief Summary
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Multicenter observational study to determine the long-term tolerability and analgesic effectiveness of oral tapentadol in patients suffering from severe pain syndromes, refractory to other strong opioids.

Detailed Description
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Tapentadol, a centrally acting analgesic. It is indicated in Europe for the relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics (IR formulation/oral solution) and for the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics (SR formulation). Tapentadol is reimbursed in Belgium since May 1, 2018. The reimbursement was obtained through an article 81 procedure (Chapter IV) which means that the reimbursement is currently restricted to the time frame of the contract and that during that period certain questions and uncertainties regarding the use of tapentadol in a Belgian setting need to be answered. In order to answer the questions raised by the Belgian Healthcare authorities, this study will be performed evaluating the application of oral tapentadol in routine clinical practice in Belgium. The study is conceived as a nation-wide multicentre prospective non-interventional trial. The primary endpoint and secondary endpoints of this study are guided by the questions that need to be answered during the course of the contract reimbursement, as established by the Belgian health authorities.

Official Title
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Multicenter Observational Study to Determine the Long-term Tolerability and Analgesic Effectiveness of Oral Tapentadol in Patients Suffering From Severe Pain Syndromes, Refractory to Other Strong Opioids.

Conditions
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Severe Pain Syndromes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects should be capable of giving their informed consent; Males and females, 18 years and older; Patients suffering from severe pain; Pain symptoms refractory to strong opioids (in previous treatment); Due to side effects Due to insufficient analgesic effectiveness Due to opioid induced hyperalgesia. Exclusion Criteria: Severe renal and/or hepatic insufficiency; Known and/or strong suspicion of allergy to tapentadol; Previous treatment with tapentadol; Presence of any condition for which tapentadol is contraindicated as per its approved labelling information in Belgium; The patient has no access to a mobile phone and web browser. During the study, an online system is used to receive messages (SMS and e-mail) for the completing of the online assessments (through web browser).

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in occurrence of gastrointestinal side effects (nausea, vomiting and constipation) between baseline and week 15 | Differences in occurence of the PRO-CTCAE items: Nausea, vomiting and constipation | baseline - week 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in frequency, severity and interference of selected side effects (dizziness, fatigue, itching, headache, dry mouth, nausea, vomiting, constipation) from baseline to week 52 | Difference in frequency, severity and interference of selected PRO-CTCAE items | baseline - week 52 | 
| Change From Baseline in Pain Scores on the Numeric Rating Scale baseline to different time points during long-term follow-up | Reduction in pain intensity numeric rating scale (PI-NRS). Scale: 0 = no pain and 10 = worst possible pain | baseline - week 52 | 
| Change of health-related quality of life from baseline to different time points during long-term follow-up | Change of healt-related quality of life measured by EQ-5D-5L (monthly evaluation) | baseline - week 52 | 
| Change of health-related quality of life from baseline to different time points during long-term follow-up | Change of healt-related quality of life measured SF-36 (monthly evaluation) | baseline - week 52 | 
| Change of functional status of the patient from baseline to different time points during long-term follow-up | Change of functional status measured by GPE-DV (monthly evaluation) | baseline - week 52 | 
| Change of functional status of the patient from baseline to different time points during long-term follow-up | Change of functional status measured by impact pain on functioning (Interference-BPI) | baseline - week 52 | 
| Change of functional status of the patient from baseline to different time points during long-term follow-up | Change of functional status measured by SF-36 (monthly evaluation) | baseline - week 52 | 
| The occurrence of tolerance during oral tapentadol treatment from baseline to different time points during long-term follow-up | Occurence of tolerance by the use of MQS-III questionnaire (weekly or monthly) | baseline - week 52 | 
| The occurrence of tolerance during oral tapentadol treatment from baseline to different time points during long-term follow-up | Occurence of tolerance by the use time-point of discontinuation of study drug | baseline - week 52 | 
| Drug conversion rates from other strong opioids to oral tapentadol from baseline to different time points during long-term follow-up | By the use of MQS-III questionnaire | baseline - week 52 |