Conversion From Fast Acting Oral Opioids to Abstral®

Study Overview
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Brief Summary
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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
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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.

Official Title
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Conversion From Fast Acting Oral Opioids to Abstral® (SL Fentanyl) in Opioid Tolerant Cancer Patients With Breakthrough Pain

Conditions
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Pain

Intervention / Treatment
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* Drug: SL fentanyl


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SL Fentanyl conversion<br>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. | Drug: SL fentanyl<br>* 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.<br>* Other names: Abstral;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate in patients converted to SL fentanyl. | 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. | 30 minutes post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate in patients converted to SL fentanyl as assessed by the PID15. |  | 15 minutes post dose | 
| 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 | 
| Patients preference of treatment (baseline treatment/SL fentanyl). |  | end of study | 
| Occurrence of AEs, withdrawals |  | during a maximum treatment period of 21 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sublingual, fentanyl, titration, conversion, breakthrough cancer pain, pain intensity difference, PID, Edmonton Symptom Assessment System, ESAS