Symptoms and General Pathology

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Cancer Pain

Pain

Breakthrough Pain

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

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Fentanyl

Morphine

Analgesics, Opioid

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

* 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.

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.

SL fentanyl

Anders Pettersson, MD, PhD

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).

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.

Conversion From Fast Acting Oral Opioids to Abstral®

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

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.

Orexo AB

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Conversion From Fast Acting Oral Opioids to Abstral®	NCT01315886	Pain	SL fentanyl	18 Years -	Orexo AB
Conversion From Fast Acting Oral Opioids to Abstral®	NCT01315886	Pain	SL fentanyl	18 Years -	Orexo AB

Spots Global Cancer Trial Database for pain intensity difference