NCT00263575

Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients

A Multiple-Dose, Non-Randomized, Open-Label, Multicenter Study to Evaluate the Long-Term Safety and Effectiveness of EN3267 in the Treatment of Breakthrough Pain in Cancer Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Cancer

Interventions

Type	Name	Description
DRUG	EN3267	EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2005-12-09
• Last updated: 2024-06-18
• Results posted: 2020-11-19

Locations

1 site across 1 country: United States