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

NCT00263575 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2024-06-18

Study results available
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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.

Conditions

Interventions

DRUG

EN3267

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

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Julian Howell · Kyowa Kirin Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-12-31
Completion
2009-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00263575 on ClinicalTrials.gov