Conditions: Pain Cancer
Keywords: EN3267 Breakthrough Pain Safety Study Fentanyl Tablets
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 139
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the long-term safety and effectiveness of EN3267 in treating breakthrough pain episodes in opioid cancer patients who are using stable doses of opioid medication.

Detailed description:
This was a Phase 3 non-randomized, open-label, multicentre study designed to evaluate the long-term safety of EN3267 in the treatment of BTcP in opioid-tolerant cancer patients. The study was conducted in 2 parts:

1. A Titration Period during which patients had up to 2 weeks to determine a single, effective dose of study medication (EN3267) for adequate treatment of BTcP, and
2. A maintenance Period of up to 12 months in which episodes of BTcP were treated with study medication.

Arms:
arm 1: None

Interventions: intervention 1: EN3267
Intervention descriptions: intervention 1: EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses

Protocol document: