Severe Pain SyndromesPLATINUMNCT03814993

taPentadol cLinical prAcTice IN belgiUM

An observational study of Severe Pain Syndromes, run by Dafne Balemans at 11 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Severe Pain Syndromes
How many people: 55 participants
Where: 11 sitesBelgium
Study dates: 29 Jul 2019to 1 Aug 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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)

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Belgium11 sites

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

Other trials in Belgium

About this study

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.

Read the 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.

Conditions: Severe Pain Syndromes
Medical subject headings: Somatoform Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: baseline - week 15

Secondary outcomes (10)

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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: baseline - week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jul 20191 Aug 2021

First posted24 Jan 2019
Study start29 Jul 2019
Primary completion1 Aug 2021
Study completion1 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Severe Pain SyndromesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03814993
Sponsor's protocol ID: PLATINUM
Acronym: PLATINUM
Status last verified: Feb 2022
First submitted: 15 Jan 2019
Last updated: 9 Feb 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Genetic Basis of Immunodeficiency
Severe Combined Immunodeficiency
RecruitingObservational study
Natural History of Acquired and Inherited Bone Marrow Failure Syndromes
Severe Aplastic Anemia, Telomere Biology Disorders
Not yet recruitingPhase 3
UBT251 Injection Phase Ⅲ Study (OSA-NPAP)
Obstructive Sleep Apnea, Obesity
Not yet recruitingPhase 1/2
SCID-X1 Gene Therapy Via Intravenous Lentiviral (Ivlv-X1) Injection
SCID, X-Linked
Active, not recruitingPhase 3
Nipocalimab in Moderate to Severe Sjogren's Disease
Sjogrens Syndrome

All Severe Pain Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT03814993
Acronym / sponsor ID: PLATINUM / PLATINUM
Conditions: Severe Pain Syndromes
Study type: Observational
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Dafne BalemansUniversity, hospital or other
Collaborators: Grünenthal GmbH
Study start: 29 Jul 2019 (actual)
Primary completion: 1 Aug 2021 (actual)
Study completion: 1 Aug 2021 (actual)
First posted: 24 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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)

Key inclusion criteria (7 listed)

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);

Key exclusion criteria (5 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

10 secondary outcomes

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
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
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 health-related quality of life from baseline to different time points during long-term follow-up
Time frame: 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 of the patient from baseline to different time points during long-term follow-up
Time frame: 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
The occurrence of tolerance during oral tapentadol treatment from baseline to different time points during long-term follow-up
Time frame: 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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.

Related trials for Severe Pain Syndromes

RecruitingObservational study
Genetic Basis of Immunodeficiency
Severe Combined Immunodeficiency
RecruitingObservational study
Natural History of Acquired and Inherited Bone Marrow Failure Syndromes
Severe Aplastic Anemia, Telomere Biology Disorders
Not yet recruitingPhase 3
UBT251 Injection Phase Ⅲ Study (OSA-NPAP)
Obstructive Sleep Apnea, Obesity
Not yet recruitingPhase 1/2
SCID-X1 Gene Therapy Via Intravenous Lentiviral (Ivlv-X1) Injection
SCID, X-Linked
Active, not recruitingPhase 3
Nipocalimab in Moderate to Severe Sjogren's Disease
Sjogrens Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Guy Hans, Prof. principal investigator

University Hospital, Antwerp

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Pain Syndromes, run by Dafne Balemans at 11 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in occurrence of gastrointestinal side effects (nausea, vomiting and constipation) between baseline and week 15 (time frame: baseline - week 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03814993.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022; AzTrials last refreshed its copy on 3 Nov 2026.