CancerPhase 3NCT00538863
Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain
A Phase 3 study testing Fentanyl sublingual spray in people with Cancer and Pain, run by INSYS Therapeutics Inc at 52 sites in 3 countries.
Trial summary
The purpose of this study was to assess the 90-day safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain in subjects on around-the-clock opioids for their persistent cancer pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Fentanyl sublingual spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- 52 sitesin 3 countries
- Study dates
- Dec 2007to Oct 2010
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects who have completed the Double-blind Period and Final Visit of protocol INS-05-001(NCT00538850), Multicenter Randomized Double-blind Trial of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain are eligible for participation in this open-label extension study.
- All de novo subjects must meet all of the following criteria to be eligible for participation in the study:
- Male or female, > 18 years of age.
- Diagnosis of cancer.
- Opioid treatment. Patients who are treated with opioids are defined as those patients who are taking at least 60 mg of oral morphine/day, at least 25 µg of transdermal fentanyl/hour, at least 30 mg of oxycodone/day, at least 8 mg of oral hydromorphone/day or an equianalgesic dose of another opioid for > 7 days for cancer-related pain.
- Experience persistent pain related to the cancer or its treatment of moderate or lesser intensity in the 24 hours prior to assessment by a verbal rating scale at the Screening Visit.
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- Experience on average 1 to 4 breakthrough cancer pain episodes per day usually at least partially controlled by supplemental medication of at least 5 mg immediate-release morphine or an equivalent short-acting opioid (eg, oxycodone, hydrocodone, or codeine with acetaminophen).
- Able to evaluate pain relief, assess medication performance, report adverse events (AEs), report use of the study drug or supplemental medication (a caregiver may provide the subject the medication).
- Able and willing to give informed consent.
- Women of childbearing potential must have a) a negative urine pregnancy test, b) not be breast feeding and c) agree to practice a reliable form of contraception.
Who cannot join
- Intolerable side effects to opioids or fentanyl.
- Rapidly increasing/uncontrolled pain.
- A history of major organ system impairment or disease, that in the Investigator's or his/her designee's opinion could increase the risk associated with the use of opioids.
- Uncontrolled hypertension (systolic blood pressure [BP] > 180 mm Hg or diastolic BP > 90 mm Hg on 2 occasions at least 6 hours apart) despite antihypertensive therapy, or has a history of hypertensive crisis within the past 2 years.
- A recent history (within the past 2 years) of transient ischemic attacks, neural vascular disease, stroke, or cerebral aneurysms.
- Serum creatinine, ALT or AST that is greater than 3 times the upper limit of normal.
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- Diagnosis of sleep apnea.
- Brain metastases with signs or symptoms of increased intracranial pressure.
- Inability to assess pain or response to pain medications for any reason, including psychiatric disorder, concurrent medical disorder, or concomitant therapy.
- Has used methadone within 14 days of the Screening Visit.
- Received an investigational study product(s) within 30 days of the Screening Visit.
- Use of monoamine oxidase (MAO) inhibitors within 14 days of the Screening Visit.
Trial locations and contacts
52 sites in 3 countries.
52 sites in 3 countries
United States40 sites
Study site
Altoona, Pennsylvania
Study site
Appleton, Wisconsin
Study site
Bellaire, Texas
Study site
Bethesda, Maryland
Study site
Bradenton, Florida
Study site
Canton, Ohio
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Danville, Pennsylvania
Study site
Dayton, Ohio
Study site
Edina, Minnesota
Study site
Elkhart, Indiana
Study site
Eugene, Oregon
Study site
Flat Rock, North Carolina
Study site
Fort Worth, Texas
Study site
Glendale, Arizona
Study site
Great Falls, Montana
Study site
Huntsville, Alabama
Study site
Jefferson City, Missouri
Study site
Kalispell, Montana
Study site
Kingsport, Tennessee
Study site
Laguna Hills, California
Study site
Lake Worth, Florida
Study site
Lemoyne, Pennsylvania
Study site
Loma Linda, California
Study site
Los Gatos, California
Study site
Miami, Florida
Study site
Missoula, Montana
Study site
Newnan, Georgia
Study site
Port Sam Houston, Texas
Study site
San Mateo, California
Study site
Scottsdale, Arizona
Study site
Skokie, Illinois
Study site
Southfield, Michigan
Study site
Tacoma, Washington
Study site
Voorhees Township, New Jersey
Study site
Winfield, Alabama
Study site
Winston-Salem, North Carolina
Study site
Winter Park, Florida
Study site
Zion, Illinois
India8 sites
Study site
Ahmedabad, India
Study site
Bangalore, India
Study site
Bhopal, India
Study site
Hyderabad, India
Study site
Jaipur, India
Study site
Mumbai, India
Study site
Nashik, India
Study site
Pune, India
Canada4 sites
Study site
Montreal, Quebec
Study site
Oakville, Ontario
Study site
Québec, Quebec
Study site
Saskatoon, Saskatchewan
About this study
Official title: Open-label Multi-center Safety Trial of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain
The purpose of this study was to assess the 90-day safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain in subjects on around-the-clock opioids for their persistent cancer pain.
Read the detailed description
This was an open-label multi-center study of the safety of fentanyl sublingual spray as a treatment for breakthrough cancer pain. The study medication was administered under the tongue as a simple spray and could be self-administered by patients or assisted by their caregivers. In addition to safety, there was a questionnaire to assess satisfaction with the study medication.
Subjects could enter this study by 1 of 2 routes:
- De novo subjects who meet the inclusion criteria and none of the exclusion criteria at the Screening Visit were enrolled into the Open-label Titration Period of the study. Upon successful completion of the titration period, patients entered the Open-label Maintenance Period.
- All patients who successfully completed the Double-blind Randomization Period and the Final Visit of study INS-05-001 (NCT00538850) were eligible to enter the Open-label Maintenance Period of this study.
- Being tested
- Fentanyl sublingual spray
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl sublingual sprayDrug
Fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, and 1600 µg
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl sublingual spray titration | Experimental | Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 26 days was reached. Receives: Drug: Fentanyl sublingual spray |
| Fentanyl sublingual spray maintenance | Experimental | Patients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects. Receives: Drug: Fentanyl sublingual spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients That Experienced 1 or More Adverse Events
Measured: Baseline to end of the study (up to 116 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
- Study startDec 2007
- Primary completionOct 2010
- Study completionOct 2010
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 CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- INSYS Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Larry Dillaha, MD, Study director, Chief Medical Officer, Insys Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538863
- Sponsor's protocol ID
- INS-06-007
- Status last verified
- Aug 2013
- First submitted
- 1 Oct 2007
- Last updated
- 11 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Multi-center Safety Trial of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain
- ClinicalTrials.gov ID
- NCT00538863
- Acronym / sponsor ID
- INS-06-007
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 3 Oct 2007 (estimated)
- Results
- Posted 11 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to assess the 90-day safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain in subjects on around-the-clock opioids for their persistent cancer pain.
Detailed description
This was an open-label multi-center study of the safety of fentanyl sublingual spray as a treatment for breakthrough cancer pain. The study medication was administered under the tongue as a simple spray and could be self-administered by patients or assisted by their caregivers. In addition to safety, there was a questionnaire to assess satisfaction with the study medication.
Subjects could enter this study by 1 of 2 routes:
- De novo subjects who meet the inclusion criteria and none of the exclusion criteria at the Screening Visit were enrolled into the Open-label Titration Period of the study. Upon successful completion of the titration period, patients entered the Open-label Maintenance Period.
- All patients who successfully completed the Double-blind Randomization Period and the Final Visit of study INS-05-001 (NCT00538850) were eligible to enter the Open-label Maintenance Period of this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl sublingual spray titration | Experimental | Drug: Fentanyl sublingual sprayPatients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 26 days was reached. |
| Fentanyl sublingual spray maintenance | Experimental | Drug: Fentanyl sublingual sprayPatients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- All subjects who have completed the Double-blind Period and Final Visit of protocol INS-05-001(NCT00538850), Multicenter Randomized Double-blind Trial of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain are eligible for participation in this open-label extension study.
- All de novo subjects must meet all of the following criteria to be eligible for participation in the study:
- Male or female, > 18 years of age.
- Diagnosis of cancer.
- Opioid treatment. Patients who are treated with opioids are defined as those patients who are taking at least 60 mg of oral morphine/day, at least 25 µg of transdermal fentanyl/hour, at least 30 mg of oxycodone/day, at least 8 mg of oral hydromorphone/day or an equianalgesic dose of another opioid for > 7 days for cancer-related pain.
Key exclusion criteria (12 listed)
- Intolerable side effects to opioids or fentanyl.
- Rapidly increasing/uncontrolled pain.
- A history of major organ system impairment or disease, that in the Investigator's or his/her designee's opinion could increase the risk associated with the use of opioids.
- Uncontrolled hypertension (systolic blood pressure [BP] > 180 mm Hg or diastolic BP > 90 mm Hg on 2 occasions at least 6 hours apart) despite antihypertensive therapy, or has a history of hypertensive crisis within the past 2 years.
- A recent history (within the past 2 years) of transient ischemic attacks, neural vascular disease, stroke, or cerebral aneurysms.
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 sublingual sprayFentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, and 1600 µg | Drug | Fentanyl sublingual spray maintenance, Fentanyl sublingual spray titration |
Primary outcome
Percentage of Patients That Experienced 1 or More Adverse Events
Time frame: Baseline to end of the study (up to 116 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Larry Dillaha, MD study director
Chief Medical Officer, Insys Therapeutics Inc
52 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fentanyl sublingual spray in people with Cancer and Pain, run by INSYS Therapeutics Inc at 52 sites in 3 countries.
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 12 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: finished, as of the sponsor's last update on 11 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, India, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 11 Oct 2013). 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?
Percentage of Patients That Experienced 1 or More Adverse Events (time frame: Baseline to end of the study (up to 116 days)). 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 11 Oct 2013.