Conversion From Fast Acting Oral Opioids to Abstral®

NCT ID: NCT01315886

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-21
• Study Completion Date: 2011-12-07

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).

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.

Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SL fentanyl

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Abstral

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orexo AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Pettersson, MD, PhD

Role: STUDY_CHAIR

Orexo AB

Locations

Smärtavdelning B42, Anestesikliniken Karolinska University Hospital, Huddinge

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

2010-020239-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OX20-005

Identifier Type: -

Identifier Source: org_study_id