Spots Global Cancer Trial Database for Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients

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Trial Identification

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

Official Title: 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

Study ID: NCT00263575

Conditions

Pain

Cancer

Interventions

EN3267

Study Description

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.