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

NCT00262678 | Completed Phase 3

• 1 other identifier: EN3267-005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Interventions

EN3267 DRUG

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Carolinas Pain Institute

Winston-Salem, North Carolina, 27103, United States

Location

Related Publications (1)

• 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.

  PMID: 19814586 DERIVED

MeSH Terms

Conditions

Pain; Neoplasms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 6, 2005
• First Posted: December 7, 2005
• Study Start: December 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: June 4, 2009

Record last verified: 2009-06

Locations

US (1)