Status:
COMPLETED
taPentadol cLinical prAcTice IN belgiUM
Lead Sponsor:
Dafne Balemans
Collaborating Sponsors:
Grünenthal GmbH
Conditions:
Severe Pain Syndromes
Eligibility:
All Genders
18+ years
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 opio...
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 formula...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 29 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03814993
Start Date
July 29 2019
End Date
August 1 2021
Last Update
February 9 2022
Active Locations (11)
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1
AZ Monic
Antwerp, Belgium, 2100
2
University Hospital Antwerp
Antwerp, Belgium, 2650
3
Huisartspraktijk Van Peer
Boechout, Belgium
4
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600