Conversion From Fast Acting Oral Opioids to Abstral® (SL Fentanyl) in Opioid Tolerant Cancer Patients With Breakthrough Pain
18 Years
N/A
Both
Pain
Trial Information
Conversion From Fast Acting Oral Opioids to Abstral® (SL Fentanyl) in Opioid Tolerant Cancer Patients With Breakthrough Pain
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate in patients converted to SL fentanyl.
Outcome Description:
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.
Outcome Time Frame:
30 minutes post dose
Safety Issue:
No
Principal Investigator
Anders Pettersson, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Orexo AB
Authority:
Sweden: Medical Products Agency
Study ID:
OX20-005
NCT ID:
NCT01315886
Start Date:
February 2011
Completion Date:
Related Keywords:
- Pain
- sublingual
- fentanyl
- titration
- conversion
- breakthrough cancer pain
- pain intensity difference
- PID
- Edmonton Symptom Assessment System
- ESAS
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