Status:
COMPLETED
Long-term Safety Study of Sublingual Fentanyl Tablets 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 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 medicati...
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 conducte...
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.
- 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
- Have previously been exposed to EN3267.
- Are pregnant or lactating.
- Have uncontrolled or rapidly escalating pain.
- Have any clinically significant condition that would, in the investigator's opinion, preclude participation in the study or compromise data collection. These conditions may include cardiopulmonary disease, and/or neurologic/psychologic conditions.
- Are scheduled to take MAOIs (monoamine oxidase inhibitors) during the study.
- Are scheduled to receive anti-neoplastic therapy that, in the investigator's opinion, will influence assessment of breakthrough pain.
- Are scheduled to receive an investigational drug other than EN3267 during the course of the study.
- Have hypersensitivity, allergy or contraindication to fentanyl.
- Have significant prior history of substance abuse or alcohol abuse.
- Would have difficulty complying with the protocol, as assessed by the investigator.
- Are unable to read, write, or comprehend the English language in order to complete diaries.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT00263575
Start Date
December 1 2005
End Date
January 1 2009
Last Update
June 18 2024
Active Locations (1)
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1
Carolinas Pain Institute
Winston-Salem, North Carolina, United States, 27103