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Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn. | Clinical Trials | Clareo Health

RECRUITINGPHASE4

Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.

NCT06498037•Erasmus Medical Center

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 120 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Key Dates

Start Date

February 23, 2024

Primary Completion Date

November 1, 2025

Completion Date

December 2, 2025

Last Updated

July 12, 2024

Enrollment

ESTIMATED participants

Conditions

Cancer Pain

Interventions

Fentanyl

DRUG

Contacts

Bram C Agema

CONTACT

+31107040704 b.agema@erasmusmc.nl

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Optimizing Subcutaneous FEntanyl titRation: RApid Achievement of Adequate Exposure When Treating Cancer-Related paIn.

Inclusion Criteria

Exclusion Criteria

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