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

Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262678
• Other study ID #: EN3267-005
• Status: Completed
• Phase: Phase 3
• First received: December 6, 2005
• Last updated: June 2, 2009
• Start date: December 2005
• Est. completion date: January 2009

Study information

• Verified date: June 2009
• Source: Prostrakan Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breakthrough Pain
• Cancer
• Pain

Intervention

Drug:
• EN3267

Locations

Country	Name	City	State
United States	Carolinas Pain Institute	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Prostrakan Pharmaceuticals

Country where clinical trial is conducted

United States,