taPentadol cLinical prAcTice IN belgiUM (PLATINUM)

Dafne Balemans

Status: Completed

Conditions: Severe Pain Syndromes

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03814993

PLATINUM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).