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

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).

Study Overview

• Status: Terminated
• Conditions: Pain
• Intervention / Treatment: Drug: SL fentanyl

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, SE-141 86
    • Smärtavdelning B42, Anestesikliniken Karolinska University Hospital, Huddinge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.; Other Names: Abstral

What is the study measuring?

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	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.

Collaborators and Investigators

• Sponsor: Orexo AB
• Investigators: Study Chair: Anders Pettersson, MD, PhD, Orexo AB

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2011
• Primary Completion (Actual): December 7, 2011
• Study Completion (Actual): December 7, 2011

Study Registration Dates

• First Submitted: March 14, 2011
• First Submitted That Met QC Criteria: March 14, 2011
• First Posted (Estimate): March 15, 2011

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: fentanyl; PID; sublingual; conversion; breakthrough cancer pain; titration; Edmonton Symptom Assessment System; ESAS; pain intensity difference
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: OX20-005; 2010-020239-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO