Suspended

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

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What is being tested

Fentanyl Nasal Spray

+ Hydromorphone PCA

+ Hydromorphone PCA

DrugOther
Who is being recruted

Neurologic Manifestations+4

+ Pathologic Processes

+ Signs and Symptoms

From 18 to 75 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 2014
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: June 29, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: January 10, 2014

Actual date on which the first participant was enrolled.

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.

NCT01812759
Principal SponsorM.D. Anderson Cancer Center
Last updated: June 29, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesEmergenciesPain

Criteria

7 inclusion criteria required to participate
Able to understand the description of the study and give informed consent
Age between 18 and 75 years
Breakthrough cancer pain must be of sufficient severity to warrant the use of intravenous opioids in the judgment of the treating emergency physician
Cancer patients presenting to the Emergency Department for treatment of acute breakthrough pain who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. (Patients considered opioid tolerant are those who are taking at least: 60 mg of oral morphine/day, 25 mcg of transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for a week or longer.)
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7 exclusion criteria prevent from participating
Patients already on high morphine equivalent daily dose (MEDDs) ( > 500 mg/day)
Patients participating in other clinical trials for pain
Patients who are not already tolerant to opioids
Patients who are pregnant or lactating
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Experimental
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Texas MD Anderson Cancer Center

Houston, United StatesOpen University of Texas MD Anderson Cancer Center in Google Maps
SuspendedOne Study Center