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

Pain Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00263575
Study type Interventional
Source Kyowa Kirin Co., Ltd.
Contact
Status Completed
Phase Phase 3
Start date December 2005
Completion date January 2009
View Details
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