Symptoms and General Pathology

All Conditions

Emergencies

Cancer Pain

Pain

Breakthrough Pain

Disease Attributes

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Fentanyl

Hydromorphone

Analgesics, Opioid

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Fentanyl 100 mcg nasal spray administered plus hydromorphone PCA. All study patients receive demand dosing patient-controlled analgesia (PCA) with intravenous hydromorphone. Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg.

Placebo nasal spray administered plus hydromorphone PCA . All study patients receive demand dosing patient-controlled analgesia (PCA) with intravenous hydromorphone. Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg.

100 mcg nasal spray administered in each nostril.

Fentanyl Nasal Spray

Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg.

Hydromorphone PCA

1 placebo nasal spray administered in each nostril.

Placebo Nasal Spray

Knox H. Todd, MD

The goal of this clinical research study is to learn if fentanyl nasal spray can help decrease pain related to cancer when used with other drugs for pain. Researchers also want to know if this drug can help decrease the length of your stay in the Emergency Department.

In this study, fentanyl nasal spray will be compared to a placebo nasal spray. A placebo is not a drug. It looks like the study drug but it is not designed to treat any disease or illness. It is designed in this study to be compared with the study spray to learn if the study spray has any real effect.

You will also be given intravenous (IV) pain drugs. You will be given these drugs even if you decide not to take part in this study.

Study Groups:

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 be performed:

* Your vital signs (blood pressure, heart rate, temperature, and breathing rate) will be recorded.
* 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.

Fentanyl for Breakthrough Pain in the Emergency Department

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

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.

Archimedes Pharma US, Inc.

M.D. Anderson Cancer Center

Placebo nasal spray administered in each nostril plus hydromorphone PCA. Initial PCA loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.

Placebo

Fentanyl 100 mcg nasal spray administered in each nostril plus hydromorphone PCA. Initial PCA loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.

Intervention

Patient consented but admitted to hospital before medication administered.

No Medication

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Pain Score between 7 and 10 using an 11-point National Rating Scale (NRS).The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

Number of Participants with Pain Score between 7 and 10 using an 11- point (NRS)

Kumar Alagappan,Chair, Emergency Medicine

One participant consented but admitted to hospital before medication administered

Number of Participants With Total Pain Relief Score (TOTPAR4) at Four Hours After Treatment Initiation.

Placebo nasal spray administered in each nostril plus hydromorphone (PCA) Initial Patient Controlled Analgesia. (PCA) loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There was no basal dose and the 8-hour dose limit was 6.4 mg.

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Dyspnea

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Morphine

Fentanyl pectin nasal (FPNS) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD). FPNS administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test. Walk test administered before first dose of FPNS. Participant will rest for 30 minutes after walk test. FPNS administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. FPNS administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes. Questionnaires completed at baseline, before each walk test, and at end of final walk test. Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.

Placebo nasal spray administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test. Walk test administered before first dose of placebo nasal spray. Participant will rest for 30 minutes after walk test. Placebo nasal spray administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. Placebo nasal spray administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes. Questionnaires completed at baseline, before each walk test, and at end of final walk test. Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.

Fentanyl pectin nasal (FPNS) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test.

Fentanyl Pectin Nasal Spray

Placebo nasal spray administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test.

Walk test administered before first dose of drug/placebo nasal spray. Participant will rest for 30 minutes after walk test. Drug/placebo nasal spray administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. Drug/placebo nasal spray administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes.

Walk Test

Questionnaires completed at baseline, before each walk test, and at end of final walk test.

Questionnaires

Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.

Mental Ability Tests

David Hui, MD

The goal of this clinical research study is to learn if fentanyl nasal spray can help to control shortness of breath in patients who have been treated or are being treated for cancer.

Fentanyl is commonly used for treatment of cancer pain. It may help patients with their shortness of breath as well.

In this study, fentanyl will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to receive either fentanyl or placebo. You will have an equal chance of being assigned to either group. Neither you nor the study staff will know to which group you have been assigned. However, if needed for your safety, the study staff will be able to find out what you are receiving.

Study Drug/Placebo Administration:

Before you receive the study drug/placebo, you will walk back and forth in an indoor hallway for up to 6 minutes. You may feel out of breath or become exhausted. You may slow down, stop, and rest at any time you need to.

After that, you will sit down and rest (for about 30 minutes).

You will then be given the study drug/placebo by a nasal spray. You will then wait for another 20 minutes and repeat the walking test.

After that, you will sit down and rest (for about 30 minutes).

You will then be given the study drug/placebo again by a nasal spray. You will then wait for another 20 minutes and repeat the walking test for a third time.

Study Visit:

During your study visit, the study staff will collect information from your medical record about your age, sex, race, disease type, your performance status, any drugs you are taking, and possible causes of shortness of breath.

Before each walk test, you will complete the questionnaires about your symptoms.

Before and after each walk test, the study staff will record your heart rate, breathing rate, and the level of oxygen in your blood using a measuring device that will be clipped onto your finger. The study staff will also ask you 3 questions about how hard it is to catch your breath and your level of tiredness.

During each walk test, you will be asked 6 times how hard it is to catch your breath. The distance you walked and how often and for how long you stopped will be recorded.

Before and after the second and third walk tests, the study staff will ask you about any side effects from the study drug/placebo that you may be having.

During the rest period between the walk tests, you may be asked several times how hard it is to catch your breath.

After each walk test, you will also be asked to complete 4 tests of your mental abilities, including finger tapping, simple mathematics questions (addition, subtraction, multiplication, division), recall of numbers, and recall of objects. It should take 15 minutes to complete these tests.

At the end of the study visit, you will complete 1 questionnaire that asks if you think the study drug/placebo is helping you, and how satisfied you are with the study. It should take about 5 minutes to complete the questionnaire.

Length of Study:

You will be on this study for up to 3 hours. You will be taken off study if intolerable side effects occur during the study.

This is an investigational study. Fentanyl is FDA approved and commercially available for the treatment of pain. Its use to help with shortness of breath is investigational.

Up to 25 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea

A Preliminary Study of Prophylactic Fentanyl Pectin Nasal Spray (FPNS) for Exercise-Induced Breakthrough Dyspnea

Our primary outcome was dyspnea intensity "now" using a dyspnea numeric rating scale that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference of dyspnea numeric rating scale between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests. 6 minute walk tests were carried out following guidelines from the American Thoracic Society.

Assessed dyspnea using the modified Dyspnea Borg Scale that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference of modified Dyspnea Borg scale between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests.

Compared the mean difference of distance between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests.

Depomed

Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).

Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.

Interventional (Fentanyl Pectin Nasal Spray) Second Walk Test

Received similar number of Placebo Spray 20 minutes before 2nd 6 minute walk tests.

Control (Placebo), Second Walk Test

Received Fentanyl Pectin Nasal Spray 20 minutes before 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.

Interventional (Fentanyl Pectin Nasal Spray),Third Walk Test

Received similar Placebo Spray 20 minutes before 3rd 6 minute walk tests.

Control (Placebo), Third Walk Test

Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd and 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.

Intervention Group (Fentanyl Pectin Nasal Spray)

Received similar number of Placebo Spray 20 minutes before 2nd and 3rd 6 minute walk tests.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fentanyl for Breakthrough Pain in the Emergency Department	NCT01812759	Pain	Fentanyl Nasal ... Hydromorphone P... Placebo Nasal S...	18 Years - 75 Years	M.D. Anderson Cancer Center
Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea	NCT01832402	Advanced Cancer...	Fentanyl Pectin... Placebo Nasal S... Walk Test Questionnaires Mental Ability ...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for placebo nasal spray