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

NCT ID: NCT00263575

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2009-01-31

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.

Conditions

Pain; Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sublingual fentanyl tablet

Group Type: EXPERIMENTAL

EN3267

Intervention Type: DRUG

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

Interventions

EN3267

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

Intervention Type: DRUG

Other Intervention Names

Fentanyl

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.

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julian Howell

Role: STUDY_DIRECTOR

Kyowa Kirin Co., Ltd.

Locations

Carolinas Pain Institute

Winston-Salem, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21208151 (View on PubMed)

Other Identifiers

EN3267-007

Identifier Type: -

Identifier Source: org_study_id