Recruiting PHASE4 Cancer Pain

New treatment option for Cancer Pain

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

ClinicalTrials.gov ID: NCT06498037

What this study is testing

What is Fentanyl?

Fentanyl is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for cancer pain.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 120

You may be able to join if

  • 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

You likely can't join if

  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Rotterdam, South Holland, Netherlands

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Rotterdam, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.