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Conversion From Fast Acting Oral Opioids to Abstral®

This study has suspended participant recruitment.
(Recruitment difficulties)
Sponsor:
Information provided by (Responsible Party):
Orexo AB
ClinicalTrials.gov Identifier:
NCT01315886
First received: March 14, 2011
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Edmonton Symptom Assessment System (ESAS) Symptom Distress Score (SDS) [ Time Frame: 24 hour assessment on days with pain episodes ] [ Designated as safety issue: No ]
  • Patient's global assessment of treatment (patient satisfaction). [ Time Frame: 2 occasions ] [ Designated as safety issue: No ]
  • Patients preference of treatment (baseline treatment/SL fentanyl). [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Occurrence of AEs, withdrawals [ Time Frame: during a maximum treatment period of 21 days. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 71
Study Start Date: February 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm 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
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: Orexo AB
ClinicalTrials.gov Identifier: NCT01315886     History of Changes
Other Study ID Numbers: OX20-005, 2010-020239-38
Study First Received: March 14, 2011
Last Updated: June 19, 2012
Health Authority: Sweden: Medical Products Agency
Norway: Norwegian Medicines Agency

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:
Fentanyl
Analgesics, Opioid
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
 Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 19, 2013