Know Cancer

or
forgot password

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


Phase 3
17 Years
N/A
Not Enrolling
Both
Pain, Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

screening and monthly study visits

Safety Issue:

Yes

Principal Investigator

Julian Howell

Investigator Role:

Study Director

Investigator Affiliation:

Prostrakan Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

EN3267-007

NCT ID:

NCT00263575

Start Date:

January 2005

Completion Date:

February 2009

Related Keywords:

  • Pain
  • Cancer
  • EN3267
  • Breakthrough Pain
  • Safety Study
  • Fentanyl Tablets

Name

Location

Carolinas Pain InstituteWinston-Salem, North Carolina  27103