Conversion From Fast Acting Oral Opioids to Abstral®
- Registration Number
- NCT01315886
- Lead Sponsor
- Orexo AB
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- Signed informed consent obtained.
- 18 years or older, of both genders.
- Opioid tolerant patients
- Estimated frequency of BTcP 0.5-4 times a day.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SL Fentanyl conversion SL fentanyl * Baseline period: 7-15 episodes of breakthrough cancer pain treated with prior IR opioid medication * Treatment period: Conversion to SL Fentanyl at a Fentanyl:Prior opioid conversion factor of 1:50 (using the estimated Morphine Sulphate Equivalent dose for the prior opioid). SL Fentanyl use was followed for 8-15 episodes of breakthrough cancer pain. SL Fentanyl dose could be titrated between episodes.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Occurrence of AEs, withdrawals during a maximum treatment period of 21 days. Responder rate in patients converted to SL fentanyl as assessed by the PID15. 15 minutes post dose Patients preference of treatment (baseline treatment/SL fentanyl). end of study Edmonton Symptom Assessment System (ESAS) Symptom Distress Score (SDS) 24 hour assessment on days with pain episodes Patient's global assessment of treatment (patient satisfaction). 2 occasions
Trial Locations
- Locations (1)
Smärtavdelning B42, Anestesikliniken Karolinska University Hospital, Huddinge
🇸🇪Stockholm, Sweden
Smärtavdelning B42, Anestesikliniken Karolinska University Hospital, Huddinge🇸🇪Stockholm, Sweden