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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

March 14, 2011
June 19, 2012
February 2011
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01315886 on ClinicalTrials.gov Archive Site
  • 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 ]
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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
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: Treatment arm
Intervention: Drug: SL fentanyl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
71
Not Provided
December 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01315886
OX20-005, 2010-020239-38
No
Orexo AB
Orexo AB
Not Provided
Study Chair: Anders Pettersson, MD, PhD Orexo AB
Orexo AB
June 2012

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