Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT03814993
Eligibility 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03814993
Study Brief:
Protocol Section:
NCT03814993