Clinical trial NCT00263575: Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Cancer
Keywords: EN3267
Breakthrough Pain
Safety Study
Fentanyl Tablets
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2005-12-09
Enrollment: 139
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 medication.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Evaluate the Long-term Safety and Effectiveness of EN3267
timeFrame: screening, 2 week titration period and 12 monthly study visits
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Carolinas Pain Institute
state: North Carolina
Study officials:
affiliation: Kyowa Kirin Co., Ltd.
name: Julian Howell
role: STUDY_DIRECTOR
References:
citation: Nalamachu S, Hassman D, Wallace MS, Dumble S, Derrick R, Howell J. Long-term effectiveness and tolerability of sublingual fentanyl orally disintegrating tablet for the treatment of breakthrough cancer pain. Curr Med Res Opin. 2011 Mar;27(3):519-30. doi: 10.1185/03007995.2010.545380. Epub 2011 Jan 6.