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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Patients are given loading doses when dose-increasing fentanyl. The concentrations at 12 and 48 hours after dose increase will be compared |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | Administration of subcutaneously administered fentanyl loading boluses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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%. | 48 hours after dose increase |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the safety of the loading bolus strategy by assessing whether CTCAE grade III or higher occur as a consequence of the fentanyl loading boluses. | This will be performed as a descriptive analysis | up to 48 hours after dose increase |
| Describe the course of patient reported pain intensity in the 48 hours following the loading boluses. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bram C Agema | Contact | +31107040704 | b.agema@erasmusmc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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a single-arm PK-study design
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This will be performed as a descriptive analysis |
| up to 48 hours after dose increase |
| Accurately assess the rate of fentanyl absorption after SC fentanyl administered as a bolus. | The pharmacokinetic data will be imputed into a population pharmacokinetic model that allows to simulate other situations and dosing regimens which will be used to further optimize dosing of subcutaneously administered fentanyl | up to 48 hours after dose increase |