Symptoms and General Pathology

All Conditions

Nervous System Diseases

Pain

Breakthrough Pain

Neurologic Manifestations

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Fentanyl

Analgesics, Opioid

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

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

EN3267

Julian Howell

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.

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.

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

Kyowa Kirin Co., Ltd.

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

Sublingual Fentanyl Tablet

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

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Fiona Miller

Patients with at least 1 AE

Patients with at least 1 AE causing discontinue

Patients with at least 1 SAE

Patients with an AE resulting in death

Titration

All patients enrolled who continued into the maintenance period

Maintenance

Combination of titration and maintenance period

Overall

Evaluate the Long-term Safety and Effectiveness of EN3267

Titration Period

Maintence Period

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients	NCT00263575	Pain Cancer	EN3267	17 Years -	Kyowa Kirin Co., Ltd.
Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients	NCT00263575	Pain Cancer	EN3267	17 Years -	Kyowa Kirin Co., Ltd.
Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients	NCT00263575	Pain Cancer	EN3267	17 Years -	Kyowa Kirin Co., Ltd.

Spots Global Cancer Trial Database for fentanyl tablets