Clinical trial NCT01839552: An Assessment of the Ability of Fentanyl Citrate Nasal Spray to Manage Breakthrough Pain in Cancer Patients.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain
Keywords: Fentanyl Citrate Nasal Spray (FCNS)
Lazanda
Breakthrough pain in cancer patients
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
First posted: 2013-04-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Lazanda is a prescription nasal spray medicine that contains the medicine fentanyl. It is used to manage breakthrough pain in adults with cancer who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Lazanda is started only after taking other opioid pain medicines and the patient's body has become used to them (opioid tolerant).

The purpose of this study is to assess the ability of Lazanda to control pain during an episode of breakthrough pain in cancer patients.


Eligibility criteria: 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 2.
  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 study.

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.

Primary outcomes:
measure: Pain Intensity
timeFrame: Assessed at end of Maintenance Stage
Secondary outcomes:
measure: Pain Management Satisfaction
timeFrame: participants will be followed during maintenance phase, up to 6 weeks
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
Study officials:
affiliation: James Graham Brown Cancer Center-University of Louisville
name: Goetz Kloecker, MD, FACP, MBA, MSPH
role: PRINCIPAL_INVESTIGATOR
References: