An observational study in Severe Pain Syndromes, sponsored by Dafne Balemans. Completed at 11 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-09.
Sponsored by Dafne Balemans · Observational
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.
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.
9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.
This study's enrollment of 55 is below the median of 102 across 2,209 observational studies indexed under Syndrome.
Browse Syndrome studies →Dafne Balemans is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients suffering from severe pain that did not respond to previous treatment with strong opioids (either due to (1) insufficient analgesic effectiveness, (2) intolerable side effects from previous opioid treatment or (3) opioid induced hyperalgesia)
Pain symptoms refractory to strong opioids (in previous treatment);
Exclusion Criteria:
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
Time frame: baseline - week 15
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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: baseline - week 52
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Dafne Balemans