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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prostrakan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00263575
First received: December 7, 2005
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Pain
Cancer
Drug: EN3267
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Prostrakan Pharmaceuticals:

Primary Outcome Measures:
  • The Study Objective is to evaluate the long-term safety and effectiveness of EN3267 in treating breakthrough pain episodes in opioid tolerant cancer patients who are using stable doses of opioid medication. [ Time Frame: screening and monthly study visits ] [ Designated as safety issue: Yes ]

Enrollment: 97
Study Start Date: January 2005
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263575

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

No publications provided by Prostrakan Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prostrakan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00263575     History of Changes
Other Study ID Numbers: EN3267-007
Study First Received: December 7, 2005
Last Updated: January 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Prostrakan Pharmaceuticals:
EN3267
Breakthrough Pain
Safety Study
Fentanyl Tablets

Additional relevant MeSH terms:
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 23, 2014