A Randomized Controlled Double-Blind Trial of Fentanyl Nasal Spray (Lazanda) Plus Hydromorphone Demand PCA Versus Placebo Nasal Spray Plus Hydromorphone Demand PCA for Treatment of Breakthrough Cancer Pain in the Emergency Department
If you agree to take part in this study, you will be randomly assigned (as in the flip of a
coin) to receive either fentanyl nasal spray or a placebo nasal spray. You will have an
equal chance of being assigned to either group.
Neither you nor the study staff will know if you are receiving the study spray or the
placebo. However, if needed for your safety, the study staff will be able to find out what
you are receiving.
Study Visit and Study Treatment:
During your stay in the Emergency Department today, the following tests and procedures will
- Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be
- Information from your medical record about your age, sex, race, status of the disease,
and any drugs that you may be taking for pain.
- The study nurse will also ask you some questions about your pain. It should take about
5 minutes to answer these questions.
You will then begin study treatment with either the fentanyl nasal spray or placebo nasal
spray. The study nurse will help you use the nasal spray.
You will stay in the Emergency Department and will be monitored for up to 8 hours after the
treatment has been administered. During this time, you will be asked about your pain and any
side effects you may be having. The study nurse will also monitor your IV pain drug levels
and other vital signs.
Length of Treatment:
Your active participation in this study will be over after your are monitored for up to 8
hours, at which time you will either be discharged to go home or admitted to the hospital
based on your pain response and any other health problems that may be found during your
visit to the Emergency Department.
Follow-Up Phone Call:
About 24 hours after your participation is over, the study nurse will call you by phone to
ask if you experienced any other side effects since finishing the study treatment. The
phone call should only last about 5 minutes. If you are still an inpatient at the hospital,
the study nurse may visit you and ask you these questions in person.
This is an investigational study. Fentanyl nasal spray is FDA approved and commercially
available for the treatment of pain. It's use to help with cancer pain in the Emergency
Department is investigational.
Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Total Pain Relief Score
Primary outcome is total pain relief score (TOTPAR4) at 4 hours after treatment initiation. TOTPAR4 defined as the sum of hourly pain relief scores after baseline to four hours after the first administered dose of Lazanda or placebo. Scores range from -1 (worse pain) to 4 (complete relief). Range of possible TOTPAR4 summed scores is -4 to 16. A TOTPAR4 score greater than or equal to 8 is considered a positive response.
Knox H. Todd, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|University of Texas MD Anderson Cancer Center||Houston, Texas 77030|