Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.
Recruiting
Phase 4
Interventional Study
Cancer Pain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 120
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 45 (estimated)
- Sponsor
- Erasmus Medical Center · Other
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About This Trial
The primary objective is to evaluate the effect of loading boluses when dose incresaing treatment with SC fentanyl in patients with cancer. The primary endpoint of this study is to prove the non-inferiority of fentanyl plasma concentrations 12 hours after dose augmentation compared to 48 hours after dose augmentation within each patient.
Patients will be treated with additional loading boluses an…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years;
* Able to understand the written information and able to give informed consent.
* Current or planned treatment with SC fentanyl for cancer-related pain
Exclusion Criteria:
* Pregnancy or/ and breastfeeding
* Other ways of using fentanyl (sublingual, nasal spra…
Contacts