Status:
COMPLETED
Efficacy and Safety of Sublingual Fentanyl Tablets in Treatment of Breakthrough Pain in Cancer Patients.
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Pain
Cancer
Eligibility:
All Genders
17+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the effectiveness and safety of sublingual fentanyl tablets in relieving breakthrough pain in cancer patients.
Eligibility Criteria
Inclusion
- Males or females 17 years of age or older
- Stable cancer-related pain.
- Are receiving a stable, fixed-schedule oral opioid regimen equivalent to 60 to 1000 mg of oral morphine per day or transdermal fentanyl therapy equivalent to 50 to 300 µg/h, and are on a stable dose of opioid medication for relief of breakthrough pain for at least 14 days prior to screening.
- Experiencing 1-4 episodes of breakthrough pain per day.
- Meet the criteria defined in the Eastern Cooperative Oncology Group (ECOG) Performance Status for Grade 0, 1, or 2.
Exclusion
- Are pregnant or lactating.
- Have uncontrolled or rapidly escalating pain.
- Have moderate to severe ulcerative mucositis.
- Have a cardiopulmonary disease that would increase the risk of administering potent opioids.
- Have neurologic or psychologic disease that would compromise data collection
- Have any clinically significant condition that would, in the investigator's opinion, preclude study participation.
- Are currently taking monoamine oxidase inhibitors (MAOIs), or have taken MAOIs within 14 days prior to enrolling in the study.
- Have received strontium 89 therapy within 60 days prior to entering the study.
- Have received anti-neoplastic therapy within 2 weeks of study entry that, in the investigator's opinion, will influence assessment of breakthrough pain
- Have received any investigational drug (non-approved) within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than EN3267 during the course of the study.
- Have hypersensitivities, allergies, or contraindications to fentanyl.
- Have a significant prior history of substance abuse or alcohol abuse.
- May have difficulty complying with the protocol, as assessed by the investigator.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00262678
Start Date
December 1 2005
End Date
January 1 2009
Last Update
June 4 2009
Active Locations (1)
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1
Carolinas Pain Institute
Winston-Salem, North Carolina, United States, 27103