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

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Pain Drug: SL fentanyl Phase 4

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  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conversion From Fast Acting Oral Opioids to Abstral® (SL Fentanyl) in Opioid Tolerant Cancer Patients With Breakthrough Pain
Actual Study Start Date : February 21, 2011
Actual Primary Completion Date : December 7, 2011
Actual Study Completion Date : December 7, 2011

Resource links provided by the National Library of Medicine

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 Name: Abstral

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Responder rate in patients converted to SL fentanyl as assessed by the PID15. [ Time Frame: 15 minutes post dose ]
  2. Edmonton Symptom Assessment System (ESAS) Symptom Distress Score (SDS) [ Time Frame: 24 hour assessment on days with pain episodes ]
  3. Patient's global assessment of treatment (patient satisfaction). [ Time Frame: 2 occasions ]
  4. Patients preference of treatment (baseline treatment/SL fentanyl). [ Time Frame: end of study ]
  5. Occurrence of AEs, withdrawals [ Time Frame: during a maximum treatment period of 21 days. ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01315886

Smärtavdelning B42, Anestesikliniken Karolinska University Hospital, Huddinge
Stockholm, Sweden, SE-141 86
Sponsors and Collaborators
Orexo AB
Study Chair: Anders Pettersson, MD, PhD Orexo AB

Responsible Party: Orexo AB Identifier: NCT01315886     History of Changes
Other Study ID Numbers: OX20-005
2010-020239-38 ( EudraCT Number )
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Orexo AB:
breakthrough cancer pain
pain intensity difference
Edmonton Symptom Assessment System

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General