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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00263575
Recruitment Status : Completed
First Posted : December 9, 2005
Results First Posted : November 19, 2020
Last Update Posted : December 16, 2020
Information provided by (Responsible Party):
Prostrakan Pharmaceuticals

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

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

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 ]

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00263575

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United States, North Carolina
Carolinas Pain Institute
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Prostrakan Pharmaceuticals
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Study Director: Julian Howell Prostrakan Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prostrakan Pharmaceuticals Identifier: NCT00263575    
Other Study ID Numbers: EN3267-007
First Posted: December 9, 2005    Key Record Dates
Results First Posted: November 19, 2020
Last Update Posted: December 16, 2020
Last Verified: January 2014
Keywords provided by Prostrakan Pharmaceuticals:
Breakthrough Pain
Safety Study
Fentanyl Tablets
Additional relevant MeSH terms:
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Breakthrough Pain
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General