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

Phase 3

Completed

• Conditions: Pain; Cancer
• Interventions: Drug: EN3267

• Registration Number: NCT00263575
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-07
• Study First Submitted QC: 2005-12-08
• Study First Posted: 2005-12-09
• Primary Completion: 2008-12
• Study Completion: 2009-01
• Results First Submitted: 2014-01-23
• Results First Submitted QC: 2020-10-27
• Results First Posted: 2020-11-19
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sublingual fentanyl tablet	EN3267	-

Primary Outcome Measures

Name	Time	Method
Evaluate the Long-term Safety and Effectiveness of EN3267	screening, 2 week titration period and 12 monthly study visits

Trial Locations

Locations (1)

Carolinas Pain Institute; 🇺🇸 Winston-Salem, North Carolina, United States