taPentadol cLinical prAcTice IN belgiUM (PLATINUM)

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.

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 Overview

• Status: Completed
• Conditions: Severe Pain Syndromes

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.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2650
    • University Hospital Antwerp
  • Antwerp, Belgium, 2100
    • AZ Monic
  • Boechout, Belgium
    • Huisartspraktijk Van Peer
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg
  • Hasselt, Belgium
    • Jessa Ziekenhuis Hasselt
  • Kortrijk, Belgium
    • AZ Groeninge
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Liège, Belgium, 4000
    • CHU Liège (Sart Tilman)
  • Mechelen, Belgium
    • Huisartspraktijk De Vaart
  • Montignies-sur-Sambre, Belgium, 6061
    • Grand Hopital Charleroi
  • Turnhout, Belgium, 2300
    • AZ Turnhout

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dafne Balemans
• Collaborators: Grünenthal GmbH
• Investigators: Principal Investigator: Guy Hans, Prof., University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2019
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: PLATINUM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No