Conversion From Fast Acting Oral Opioids to Abstral®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01315886
Recruitment Status : Terminated (Recruitment difficulties)
First Posted : March 15, 2011
Last Update Posted : April 5, 2017
Information provided by (Responsible Party):
Orexo AB

March 14, 2011
March 15, 2011
April 5, 2017
February 21, 2011
December 7, 2011   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01315886 on Archive Site
  • 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. ]
Same as current
Not Provided
Not Provided
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).
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.
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Name: Abstral
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.
Intervention: Drug: SL fentanyl
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 7, 2011
December 7, 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
2010-020239-38 ( EudraCT Number )
Not Provided
Plan to Share IPD: No
Orexo AB
Orexo AB
Not Provided
Study Chair: Anders Pettersson, MD, PhD Orexo AB
Orexo AB
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP