A European multicenter open-label study of breakthrough cancer pain: assessment of fentanyl buccal tablets titration and treatment in opioid-tolerant patients.

Phase 4

• Conditions: breakthrough pain; cancer; 10027656

• Registration Number: NL-OMON32331
• Lead Sponsor: Cephalon France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 63

Inclusion Criteria

- The patient has a histologically documented diagnosis of cancer (ie, a solid tumor or hematologic malignancy).
- The patient has stable background pain due to cancer.
- The patient experiences, on average, up to 4 BTP episodes per 24 hours occurring at the location of the chronic pain, while taking maintenance opioid therapy.
- As maintenance opioid therapy, the patient is currently taking 1 of the folowing: at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone/day, at least 8 mg of hydromorphone/day, of an equianalgesic dose of another opioid for a week or longer before administration of the first dose of study drug.

Exclusion Criteria

- The patient is without maintenance opioid therapy, as there is an increased risk of respiratory depression.
- The patient has uncontrolled or rapidly escalating pain as determined by the investigator (i.e., the maintenance opioid therapy may be expected to change between the first and last treatments with study drug), or has pain uncontrolled by therapy that could adversely impact the safety of the patient or that could be compromised by treatment with study drug.
- The patient has known or suspected hypersensitivities, allergies, or other contraindications to the active drug or to any of the excipients of the study drug.
- The patient has respiratory depression or chronic obstructive pulmonary disease, or any other medical condition predisposing to respiratory depression.

Study & Design

• Study Type: Interventional
• Study Design: Not specified