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An Assessment of the Ability of Fentanyl Citrate Nasal Spray to Manage Breakthrough Pain in Cancer Patients Without a Timely Response to Their Short-acting Opioids.

Phase 4
18 Years
Not Enrolling

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Trial Information

An Assessment of the Ability of Fentanyl Citrate Nasal Spray to Manage Breakthrough Pain in Cancer Patients Without a Timely Response to Their Short-acting Opioids.

Inclusion Criteria:

- Patients who meet the following criteria will be eligible:

1. At least 18 years of age or older.

2. Diagnosed with cancer.

3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or

4. Patients with cancer who are experiencing episodes of BTPc in spite of optimized
background analgesia with at least 60 mg/day of morphine (or equivalent
analgesic) for at least 7 days.

5. Patients with cancer currently using an SAO (short acting opioid) to manage
their episodes of BTPc.

6. Patients with cancer who have failed to obtain a timely response, as determined
by the Principal Investigator, to pain from their SAO therapy.

7. Laboratory values consistent with the stage of disease that are deemed
clinically insignificant by the investigator.

8. Female patients of child bearing potential or male patients with partners of
child bearing potential who are using an adequate form of contraception before
study entry, and agree to use an adequate form of contraception for an
additional month after the study. Adequate contraception is defined as the use
of any hormonal contraception or intra-uterine device by the female
patient/partner plus use by at least 1 of the partners of an additional
spermicide-containing barrier method of contraception. The use of a barrier
method alone or abstinence is not considered adequate.

9. Willing and able to give written informed consent before participating in the

Exclusion Criteria:

- Patients meeting the following criteria will be excluded from the study:

1. Patients who are not opioid tolerant.

2. Patients with a known intolerance or hypersensitivity to fentanyl.

3. Physical abnormalities of the nose that could affect nasal absorption.

4. Patients with uncontrolled or rapidly escalating pain.

5. Patients with a history of alcohol or substance abuse.

6. A clinically significant medical history (past or present) of any disease that
would compromise the study or the well-being of the patient .

7. Patients who have participated in another clinical trial with an analgesic
within the last month.

8. Patients who have previously used FCNS and did not have adequate responses.

9. Female patients with a positive pregnancy test or who are currently lactating.

10. Patients who are taking medications that are known inhibitors of the CYP3A4
isoenzyme, such as ketoconazole.

11. Patients who have taken a monoamine oxidase inhibitor within 14 days before a
dose of study medication.

12. Patients who are unsuitable for inclusion for any other reason, in the opinion
of the investigator.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Pain Intensity

Outcome Description:

The primary efficacy outcome measure is pain intensity difference at 15 minutes (PID15) after dosing during the Maintenance Stage. (PID15 is defined as the difference between pain intensity at 15 minutes and baseline.)Maintenance stage is defined as 6 breakthrough pain episodes for up to 6 weeks.

Outcome Time Frame:

Assessed at end of Maintenance Stage

Safety Issue:


Principal Investigator

Goetz Kloecker, MD, FACP, MBA, MSPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center-University of Louisville


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Pain
  • Fentanyl Citrate Nasal Spray (FCNS)
  • Lazanda
  • Breakthrough pain in cancer patients



James Graham Brown Cancer CenterLouisville, Kentucky  40202