Efficacy and Safety of Sublingual Fentanyl Tablets in Treatment of Breakthrough Pain in Cancer Patients.

NCT ID: NCT00262678

Last Updated: 2009-06-04

Basic Information

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

Brief Summary

The purpose of this study is to determine the effectiveness and safety of sublingual fentanyl tablets in relieving breakthrough pain in cancer patients.

Conditions

Pain; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

EN3267

Intervention Type: DRUG

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 for at least 14 days prior to screening.
• 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

• Are pregnant or lactating.
• Have uncontrolled or rapidly escalating pain.
• Have moderate to severe ulcerative mucositis.
• Have a cardiopulmonary disease that would increase the risk of administering potent opioids.
• Have neurologic or psychologic disease that would compromise data collection
• Have any clinically significant condition that would, in the investigator's opinion, preclude study participation.
• Are currently taking monoamine oxidase inhibitors (MAOIs), or have taken MAOIs within 14 days prior to enrolling in the study.
• Have received strontium 89 therapy within 60 days prior to entering the study.
• Have received anti-neoplastic therapy within 2 weeks of study entry that, in the investigator's opinion, will influence assessment of breakthrough pain
• Have received any investigational drug (non-approved) within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than EN3267 during the course of the study.
• Have hypersensitivities, allergies, or contraindications to fentanyl.
• Have a significant prior history of substance abuse or alcohol abuse.
• May have difficulty complying with the protocol, as assessed by the investigator.

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

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Locations

Carolinas Pain Institute

Winston-Salem, North Carolina, United States

Countries

United States

References

Rauck RL, Tark M, Reyes E, Hayes TG, Bartkowiak AJ, Hassman D, Nalamachu S, Derrick R, Howell J. Efficacy and long-term tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain. Curr Med Res Opin. 2009 Dec;25(12):2877-85. doi: 10.1185/03007990903368310.

Reference Type: DERIVED

PMID: 19814586 (View on PubMed)

Other Identifiers

EN3267-005

Identifier Type: -

Identifier Source: org_study_id