taPentadol cLinical prAcTice IN belgiUM (PLATINUM)

• ClinicalTrials.gov Identifier: NCT03814993
• Recruitment Status: Completed
• First Posted: January 24, 2019
• Last Update Posted: February 9, 2022
• Sponsor: Dafne Balemans
• Collaborator: Grünenthal GmbH
• Information provided by (Responsible Party): Dafne Balemans, University Hospital, Antwerp

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 55 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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.
• Actual Study Start Date: July 29, 2019
• Actual Primary Completion Date: August 1, 2021
• Actual Study Completion Date: August 1, 2021

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Difference in occurrence of gastrointestinal side effects (nausea, vomiting and constipation) between baseline and week 15 [ Time Frame: baseline - week 15 ]
   Differences in occurence of the PRO-CTCAE items: Nausea, vomiting and constipation

Secondary Outcome Measures :

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

Eligibility Criteria

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

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).

Contacts and Locations

Locations

Belgium

AZ Monic

Antwerp, Belgium, 2100

University Hospital Antwerp

Antwerp, Belgium, 2650

Huisartspraktijk Van Peer

Boechout, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium, 3600

Jessa Ziekenhuis Hasselt

Hasselt, Belgium

AZ Groeninge

Kortrijk, Belgium

UZ Leuven

Leuven, Belgium, 3000

CHU Liège (Sart Tilman)

Liège, Belgium, 4000

Huisartspraktijk De Vaart

Mechelen, Belgium

Grand Hôpital Charleroi

Montignies-sur-Sambre, Belgium, 6061

AZ Turnhout

Turnhout, Belgium, 2300

Sponsors and Collaborators

Dafne Balemans

Grünenthal GmbH

Investigators

• Principal Investigator: Guy Hans, Prof.; University Hospital, Antwerp

More Information

• Responsible Party: Dafne Balemans, Clinical Trial Center UZA, University Hospital, Antwerp
• ClinicalTrials.gov Identifier: NCT03814993
• Other Study ID Numbers: PLATINUM
• First Posted: January 24, 2019
• Last Update Posted: February 9, 2022
• Last Verified: February 2022

• 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

Additional relevant MeSH terms:

Syndrome; Disease; Pathologic Processes