Conversion From Fast Acting Oral Opioids to Abstral®

Phase 4TerminatedNCT01315886

Orexo AB8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain

Interventions

SL fentanylDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Smärtavdelning B42, Anestesikliniken Karolinska University Hospital, Huddinge

Stockholm, Sweden

Outcomes

Primary Outcomes

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.

Time frame: 30 minutes post dose

Secondary Outcomes

Responder rate in patients converted to SL fentanyl as assessed by the PID15.

Time frame: 15 minutes post dose

Edmonton Symptom Assessment System (ESAS) Symptom Distress Score (SDS)

Time frame: 24 hour assessment on days with pain episodes

Patient's global assessment of treatment (patient satisfaction).

Time frame: 2 occasions

Patients preference of treatment (baseline treatment/SL fentanyl).

Time frame: end of study

Occurrence of AEs, withdrawals

Time frame: during a maximum treatment period of 21 days.

Data from ClinicalTrials.gov

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