Conversion From Fast Acting Oral Opioids to Abstral®

Orexo

Status and phase: Terminated; Phase 4

Conditions: Pain

Treatments: Drug: SL fentanyl

Study type: Interventional

Funder types: Industry

Identifiers

NCT01315886

OX20-005

2010-020239-38 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

SL Fentanyl conversion

Experimental group

Description:

* 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.

Treatment:

Drug: SL fentanyl