PainPhase 4NCT01812759
Fentanyl for Breakthrough Pain in the Emergency Department
A Phase 4 study testing Fentanyl Nasal Spray and Hydromorphone PCA in people with Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- Fentanyl Nasal Spray and Hydromorphone PCA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2014to 22 Oct 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
- Patients must have severe pain on an 11-point Numeric Rating Scale (NRS 7-10)
- Breakthrough cancer pain must be of sufficient severity to warrant the use of intravenous opioids in the judgment of the treating emergency physician
- Age between 18 and 75 years
- Able to understand the description of the study and give informed consent
- Patients must be willing to and capable of providing frequent pain assessments for up to 8 hours
- English-speaking
Who cannot join
- Patients will not be approached while they are in acute distress and those exhibiting symptoms (such as dyspnea, uncontrolled nausea/vomiting or vertigo) to such an extent that impairs their ability to understand and evaluate informed consent
- Patients participating in other clinical trials for pain
- Patients who are not already tolerant to opioids
- Patients, who in the judgment of the treating clinician, are suspected to have hepatic or renal failure
- Patients who are pregnant or lactating
- Patients with a known allergy or significant reaction to fentanyl, the components of the IN formulation, hydromorphone, or other opioids
- Patients already on high morphine equivalent daily dose (MEDDs) (>500 mg/day).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Pain
- Being tested
- Fentanyl Nasal Spray, Hydromorphone PCA, Placebo Nasal Spray
- Keywords
- Pain, Breakthrough cancer pain, Emergency Department, ED, Fentanyl nasal spray, Lazanda, Placebo nasal spray, Hydromorphone PCA, Dilaudid
- Medical subject headings
- Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl Nasal SprayDrug
Also called Lazanda
100 mcg nasal spray administered in each nostril.
Hydromorphone PCADrug
Also called Dilaudid
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 SprayOther
1 placebo nasal spray administered in each nostril.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl Nasal Spray + Hydromorphone PCA | 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. Receives: Drug: Fentanyl Nasal Spray; Drug: Hydromorphone PCA |
| Placebo Nasal Spray + Hydromorphone PCA | 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. Receives: Drug: Hydromorphone PCA; Other: Placebo Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Total Pain Relief Score (TOTPAR4) at Four Hours After Treatment Initiation.
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.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study start10 Jan 2014
- Primary completion22 Oct 2014
- Study completion22 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Archimedes Pharma US, Inc.
- Responsible party
- Sponsor
- Investigators
- Knox H. Todd, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812759
- Sponsor's protocol ID
- 2012-0982
- Other IDs
- NCI-2014-00915
- Status last verified
- Jun 2021
- First submitted
- 14 Mar 2013
- Last updated
- 29 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01812759
- Acronym / sponsor ID
- 2012-0982
- Conditions
- Pain
- Keywords
- Pain, Breakthrough cancer pain, Emergency Department, ED, Fentanyl nasal spray, Lazanda, Placebo nasal spray, Hydromorphone PCA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Archimedes Pharma US, Inc.
- Study start
- 10 Jan 2014 (actual)
- Primary completion
- 22 Oct 2014 (actual)
- Study completion
- 22 Oct 2014 (actual)
- First posted
- 18 Mar 2013 (estimated)
- Results
- Posted 14 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl Nasal Spray + Hydromorphone PCA | Experimental | Drug: Fentanyl Nasal Spray, Drug: Hydromorphone PCAFentanyl 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 + Hydromorphone PCA | Experimental | Drug: Hydromorphone PCA, Other: Placebo Nasal SprayPlacebo 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.)
- Patients must have severe pain on an 11-point Numeric Rating Scale (NRS 7-10)
- Breakthrough cancer pain must be of sufficient severity to warrant the use of intravenous opioids in the judgment of the treating emergency physician
- Age between 18 and 75 years
- Able to understand the description of the study and give informed consent
Key exclusion criteria (7 listed)
- Patients will not be approached while they are in acute distress and those exhibiting symptoms (such as dyspnea, uncontrolled nausea/vomiting or vertigo) to such an extent that impairs their ability to understand and evaluate informed consent
- Patients participating in other clinical trials for pain
- Patients who are not already tolerant to opioids
- Patients, who in the judgment of the treating clinician, are suspected to have hepatic or renal failure
- Patients who are pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl Nasal SprayAlso: Lazanda100 mcg nasal spray administered in each nostril. | Drug | Fentanyl Nasal Spray + Hydromorphone PCA |
| Hydromorphone PCAAlso: DilaudidInitial 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. | Drug | Fentanyl Nasal Spray + Hydromorphone PCA, Placebo Nasal Spray + Hydromorphone PCA |
| Placebo Nasal Spray1 placebo nasal spray administered in each nostril. | Other | Placebo Nasal Spray + Hydromorphone PCA |
Primary outcome
Number of Participants With Total Pain Relief Score (TOTPAR4) at Four Hours After Treatment Initiation.
Time frame: 4 hours
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knox H. Todd, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl Nasal Spray and Hydromorphone PCA in people with Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Total Pain Relief Score (TOTPAR4) at Four Hours After Treatment Initiation. (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.