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Conversion From Fast Acting Oral Opioids to Abstral®

This study has been terminated.
(Recruitment difficulties)
Sponsor:
Information provided by (Responsible Party):
Orexo AB
ClinicalTrials.gov Identifier:
NCT01315886
First received: March 14, 2011
Last updated: April 3, 2017
Last verified: April 2017
  Purpose
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 Intervention Phase
Pain Drug: SL fentanyl Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Conversion From Fast Acting Oral Opioids to Abstral® (SL Fentanyl) in Opioid Tolerant Cancer Patients With Breakthrough Pain

Resource links provided by NLM:


Further study details as provided by Orexo AB:

Primary Outcome 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 Outcome 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. ]

Enrollment: 8
Actual Study Start Date: February 21, 2011
Study Completion Date: December 7, 2011
Primary Completion Date: December 7, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315886

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

Responsible Party: Orexo AB
ClinicalTrials.gov Identifier: NCT01315886     History of Changes
Other Study ID Numbers: OX20-005
2010-020239-38 ( EudraCT Number )
Study First Received: March 14, 2011
Last Updated: April 3, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Orexo AB:
sublingual
fentanyl
titration
conversion
breakthrough cancer pain
pain intensity difference
PID
Edmonton Symptom Assessment System
ESAS

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

ClinicalTrials.gov processed this record on June 23, 2017