Conversion From Fast Acting Oral Opioids to Abstral®

• Status: Terminated
• Trial end date: 2011-12-07
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orexo AB
• Treatments: Fentanyl

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.