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

• ClinicalTrials.gov Identifier: NCT00263575
• Recruitment Status: Completed
• First Posted: December 9, 2005
• Results First Posted: November 19, 2020
• Last Update Posted: December 16, 2020
• Sponsor: Prostrakan Pharmaceuticals
• Information provided by (Responsible Party): Prostrakan Pharmaceuticals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain; Cancer	Drug: EN3267	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 139 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multiple-Dose, Non-Randomized, Open-Label, Multicenter Study to Evaluate the Long-Term Safety and Effectiveness of EN3267 in the Treatment of Breakthrough Pain in Cancer Patients
• Study Start Date: December 2005
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: January 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: sublingual fentanyl tablet	Drug: EN3267; EN3267 will be available in 100, 200, 300, 400, 600 (two 300 ug tablets), and 800 ug (two 400 ug tablets) doses; Other Name: Fentanyl

Outcome Measures

Primary Outcome Measures :

1. Evaluate the Long-term Safety and Effectiveness of EN3267 [ Time Frame: screening, 2 week titration period and 12 monthly study visits ]

Eligibility Criteria

• Ages Eligible for Study: 17 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, North Carolina

Carolinas Pain Institute

Winston-Salem, North Carolina, United States, 27103

Sponsors and Collaborators

Prostrakan Pharmaceuticals

Investigators

• Study Director: Julian Howell; Prostrakan Pharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Prostrakan Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00263575
• Other Study ID Numbers: EN3267-007
• First Posted: December 9, 2005
• Results First Posted: November 19, 2020
• Last Update Posted: December 16, 2020
• Last Verified: January 2014

Keywords provided by Prostrakan Pharmaceuticals:

EN3267; Breakthrough Pain; Safety Study; Fentanyl Tablets

Additional relevant MeSH terms:

Breakthrough Pain; Pain; Neurologic Manifestations; Fentanyl; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Anesthetics