taPentadol cLinical prAcTice IN belgiUM (PLATINUM)

February 8, 2022 updated by: Dafne Balemans

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline - week 15

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: baseline - 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
Time Frame: baseline - week 52
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
Time Frame: baseline - week 52
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
Time Frame: baseline - week 52
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
Time Frame: baseline - week 52
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
Time Frame: baseline - week 52
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
Time Frame: baseline - week 52
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
Time Frame: baseline - week 52
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
Time Frame: baseline - week 52
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
Time Frame: baseline - week 52
By the use of MQS-III questionnaire
baseline - week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dafne Balemans

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Grünenthal GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guy Hans, Prof., University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 29, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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