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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prostrakan Pharmaceuticals
• Treatments: Fentanyl

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.