Conversion From Fast Acting Oral Opioids to Abstral®

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).

Full Title of Study: “Conversion From Fast Acting Oral Opioids to Abstral® (SL Fentanyl) in Opioid Tolerant Cancer Patients With Breakthrough Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 7, 2011

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.

Interventions

  • Drug: SL fentanyl
    • 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.

Arms, Groups and Cohorts

  • Experimental: SL Fentanyl conversion
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Response rate in patients converted to SL fentanyl.
    • Time Frame: 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 Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Orexo AB
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anders Pettersson, MD, PhD, Study Chair, Orexo AB

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