Clinical trial · Interventional
Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.
NCT06498037CI-TRIAL-00078764FERRARIunknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 and plasma-PK samples will be obtained.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention arm
- description
- Patients are given loading doses when dose-increasing fentanyl. The concentrations at 12 and 48 hours after dose increase will be compared
- interventionNames
- Drug: Fentanyl
Primary outcomes (1)
- measure
- Primary endpoint of this study is to prove the non-inferiority in fentanyl plasma concentrations 12 hours after dose augmentation compared to 48 hours after dose augmentation within each patient using a bioequivalence approach
- timeFrame
- 48 hours after dose increase
- description
- Using a paired t-test the geometric mean of the ratio of the two fentanyl plasma concentrations will be compared. The 90% confidence interval of the geomteric mean should fall within the range of 80 - 125%.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 spray and oromucosal) * Liver function CPS B or C * The use of strong CYP3A4 inhibitors of inducers \[9\] * Presence of somnolence, respiratory depression or CTCAE grade 2 adverse events.
References
Publications (0)
Data not yet available
No reference posted for this study.