Pain
Conditions
Keywords
sublingual, fentanyl, titration, conversion, breakthrough cancer pain, pain intensity difference, PID, Edmonton Symptom Assessment System, ESAS
Brief summary
The purpose of this study is to evaluate safety and efficacy when using a novel dose conversion strategy to switch from immediate release oral opioids to sublingual (SL) fentanyl (Abstral) for treatment of breakthrough cancer pain (BTcP).
Detailed description
The study aims to show that in the advanced stage of cancer the individual patient already on high doses of BTcP medication will benefit from starting treatment on a higher first dose of SL fentanyl thus reducing the number of dosing steps with insufficient pain relief.
Interventions
DRUGSL fentanyl
SL fentanyl will be administered during 7- 15 BTcP episodes during a maximum period of 21 days, following a baseline period with standard BTcP treatment. The start dose of SL fentanyl is selected individually according to a standardized conversion ratio. The maximum start dose is limited to 400 μg. For a single BTcP episode no more than two (2) tablets or a maximum dose of 800 μg should be given.
Sponsors
Orexo AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent obtained. * 18 years or older, of both genders. * Opioid tolerant patients * Estimated frequency of BTcP 0.5-4 times a day.
Exclusion criteria
* Treatment with SL fentanyl within two weeks prior to screening. * Recent or planned therapy that would alter pain or responses to analgesics. * Treatment with monoamine oxidase inhibitor \< 14 days before or concurrent with SL fentanyl treatment. * Significantly reduced liver and/or kidney function. * Significant prior history of substance abuse. * Pregnancy, breast feeding or woman of childbearing potential not using adequate birth control.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate in patients converted to SL fentanyl. | 30 minutes post dose | A subject is defined as responder if the change of Pain Intensity (PI) on the Numerical Rating Scale (NRS) rated from 0 to 10, at 30 minutes (PID30) is similar or higher after the conversion to SL fentanyl compared to baseline PID30 as assessed by standard care rescue treatment of BTcP episodes. |
Secondary
| Measure | Time frame |
|---|---|
| Edmonton Symptom Assessment System (ESAS) Symptom Distress Score (SDS) | 24 hour assessment on days with pain episodes |
| Responder rate in patients converted to SL fentanyl as assessed by the PID15. | 15 minutes post dose |
| Patient's global assessment of treatment (patient satisfaction). | 2 occasions |
| Patients preference of treatment (baseline treatment/SL fentanyl). | end of study |
| Occurrence of AEs, withdrawals | during a maximum treatment period of 21 days. |
Countries
Sweden
Outcome results
None listed