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

This study has been completed.
Information provided by:
Prostrakan Pharmaceuticals
ClinicalTrials.gov Identifier:
First received: December 6, 2005
Last updated: June 2, 2009
Last verified: June 2009

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

Condition Intervention Phase
Drug: EN3267
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of EN3267 for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients.

Resource links provided by NLM:

Further study details as provided by Prostrakan Pharmaceuticals:

Study Start Date: December 2005
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262678

United States, North Carolina
Carolinas Pain Institute
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Prostrakan Pharmaceuticals
  More Information

No publications provided by Prostrakan Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00262678     History of Changes
Other Study ID Numbers: EN3267-005
Study First Received: December 6, 2005
Last Updated: June 2, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014