Clinical trial NCT03814993: taPentadol cLinical prAcTice IN belgiUM
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Pain Syndromes
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Grünenthal GmbH
First posted: 2019-01-24
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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)

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Difference in occurrence of gastrointestinal side effects (nausea, vomiting and constipation) between baseline and week 15
timeFrame: baseline - week 15
Secondary outcomes:
measure: Difference in frequency, severity and interference of selected side effects (dizziness, fatigue, itching, headache, dry mouth, nausea, vomiting, constipation) from baseline to week 52
timeFrame: baseline - week 52
measure: Change From Baseline in Pain Scores on the Numeric Rating Scale baseline to different time points during long-term follow-up
timeFrame: baseline - week 52
measure: Change of health-related quality of life from baseline to different time points during long-term follow-up
timeFrame: baseline - week 52
measure: Change of health-related quality of life from baseline to different time points during long-term follow-up
timeFrame: baseline - week 52
measure: Change of functional status of the patient from baseline to different time points during long-term follow-up
timeFrame: baseline - week 52
measure: Change of functional status of the patient from baseline to different time points during long-term follow-up
timeFrame: baseline - week 52
measure: Change of functional status of the patient from baseline to different time points during long-term follow-up
timeFrame: baseline - week 52
measure: The occurrence of tolerance during oral tapentadol treatment from baseline to different time points during long-term follow-up
timeFrame: baseline - week 52
measure: The occurrence of tolerance during oral tapentadol treatment from baseline to different time points during long-term follow-up
timeFrame: baseline - week 52
measure: Drug conversion rates from other strong opioids to oral tapentadol from baseline to different time points during long-term follow-up
timeFrame: baseline - week 52
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: AZ Monic
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
city: Boechout
country: Belgium
facility: Huisartspraktijk Van Peer
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis Hasselt
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHU Liège (Sart Tilman)
city: Mechelen
country: Belgium
facility: Huisartspraktijk De Vaart
city: Montignies-sur-Sambre
country: Belgium
facility: Grand Hôpital Charleroi
city: Turnhout
country: Belgium
facility: AZ Turnhout
Study officials:
affiliation: University Hospital, Antwerp
name: Guy Hans, Prof.
role: PRINCIPAL_INVESTIGATOR
References: