PainPhase 4FCNSNCT01839552
An Assessment of the Ability of Fentanyl Citrate Nasal Spray to Manage Breakthrough Pain in Cancer Patients.
A Phase 4 study testing Fentanyl Citrate Nasal Spray (FCNS) in people with Pain, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Fentanyl Citrate Nasal Spray (FCNS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Apr 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet the following criteria will be eligible:
- At least 18 years of age or older.
- Diagnosed with cancer.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- 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.
- Patients with cancer currently using an SAO (short acting opioid) to manage their episodes of BTPc.
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- Patients with cancer who have failed to obtain a timely response, as determined by the Principal Investigator, to pain from their SAO therapy.
- Laboratory values consistent with the stage of disease that are deemed clinically insignificant by the investigator.
- 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.
- Willing and able to give written informed consent before participating in the study.
Who cannot join
- Patients meeting the following criteria will be excluded from the study:
- Patients who are not opioid tolerant.
- Patients with a known intolerance or hypersensitivity to fentanyl.
- Physical abnormalities of the nose that could affect nasal absorption.
- Patients with uncontrolled or rapidly escalating pain.
- Patients with a history of alcohol or substance abuse.
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- A clinically significant medical history (past or present) of any disease that would compromise the study or the well-being of the patient .
- Patients who have participated in another clinical trial with an analgesic within the last month.
- Patients who have previously used FCNS and did not have adequate responses.
- Female patients with a positive pregnancy test or who are currently lactating.
- Patients who are taking medications that are known inhibitors of the CYP3A4 isoenzyme, such as ketoconazole.
- Patients who have taken a monoamine oxidase inhibitor within 14 days before a dose of study medication.
- Patients who are unsuitable for inclusion for any other reason, in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
About this study
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.
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.
- Conditions
- Pain
- Being tested
- Fentanyl Citrate Nasal Spray (FCNS)
- Keywords
- Fentanyl Citrate Nasal Spray (FCNS), Lazanda, Breakthrough pain in cancer patients
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl Citrate Nasal Spray (FCNS)Drug
Also called Lazanda
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl Citrate Nasal Spray (FCNS) | Experimental | Treatment for breakthrough pain with Fentanyl Citrate Nasal Spray (FCNS) Receives: Drug: Fentanyl Citrate Nasal Spray (FCNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
The primary efficacy outcome measure is pain intensity difference at 15 minutes (PID15) after dosing during the Maintenance Stage. (PID15 is defined as the difference between pain intensity at 15 minutes and baseline.)Maintenance stage is defined as 6 breakthrough pain episodes for up to 6 weeks.
Measured: Assessed at end of Maintenance Stage
Secondary outcomes (1)
Pain Management Satisfaction
The key secondary outcome measure is the proportion of episodes that the patient defines as satisfactorily managed at 15 minutes.
Satisfaction will be considered to have been achieved for an individual episode of BTPc(Breakthrough pain)if the patient rates pain management as "Satisfied" or "Very Satisfied." Patients complete a satisfaction questionnaire at end of study.
Measured: participants will be followed during maintenance phase, up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startOct 2014
- Primary completionApr 2017 (estimated)
- Study completionApr 2018 (estimated)
Why it stopped: Site chose to close due to lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Principal investigator, Goetz Kloecker, University of Louisville
- Investigators
- Goetz Kloecker, MD, FACP, MBA, MSPH, Principal investigator, James Graham Brown Cancer Center-University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839552
- Sponsor's protocol ID
- BCC-CA-12
- Acronym
- FCNS
- Status last verified
- Mar 2018
- First submitted
- 10 Apr 2013
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01839552
- Acronym / sponsor ID
- FCNS / BCC-CA-12
- Conditions
- Pain
- Keywords
- Fentanyl Citrate Nasal Spray (FCNS), Lazanda, Breakthrough pain in cancer patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Site chose to close due to lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Oct 2014
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 25 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fentanyl Citrate Nasal Spray (FCNS) | Experimental | Drug: Fentanyl Citrate Nasal Spray (FCNS)Treatment for breakthrough pain with Fentanyl Citrate Nasal Spray (FCNS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients who meet the following criteria will be eligible:
Key exclusion criteria (13 listed)
- Patients meeting the following criteria will be excluded from the study:
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 Citrate Nasal Spray (FCNS)Also: Lazanda | Drug | Fentanyl Citrate Nasal Spray (FCNS) |
Primary outcome
Pain Intensity
Time frame: Assessed at end of Maintenance Stage
The primary efficacy outcome measure is pain intensity difference at 15 minutes (PID15) after dosing during the Maintenance Stage. (PID15 is defined as the difference between pain intensity at 15 minutes and baseline.)Maintenance stage is defined as 6 breakthrough pain episodes for up to 6 weeks.
1 secondary outcome
Pain Management Satisfaction
Time frame: participants will be followed during maintenance phase, up to 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
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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.
Goetz Kloecker, MD, FACP, MBA, MSPH principal investigator
James Graham Brown Cancer Center-University of Louisville
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 Citrate Nasal Spray (FCNS) in people with Pain, run by University of Louisville 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 10 inclusion and 13 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: withdrawn, as of the sponsor's last update on 5 Mar 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain Intensity (time frame: Assessed at end of Maintenance Stage). 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 5 Mar 2018.