Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain
NCT ID: NCT00538863
Last Updated: 2013-10-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
319 participants
INTERVENTIONAL
2007-12-31
2010-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Fentanyl sublingual spray titration
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.
Fentanyl sublingual spray
Fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, and 1600 µg
Fentanyl sublingual spray maintenance
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.
Fentanyl sublingual spray
Fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, and 1600 µg
Interventions
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Fentanyl sublingual spray
Fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, and 1600 µg
Eligibility Criteria
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Inclusion Criteria
All de novo subjects must meet all of the following criteria to be eligible for participation in the study:
1. Male or female, \> 18 years of age.
2. Diagnosis of cancer.
3. 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.
4. 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.
5. 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).
6. 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).
7. Able and willing to give informed consent.
8. 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.
Exclusion Criteria
2. Rapidly increasing/uncontrolled pain.
3. 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.
4. 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.
5. A recent history (within the past 2 years) of transient ischemic attacks, neural vascular disease, stroke, or cerebral aneurysms.
6. Serum creatinine, ALT or AST that is greater than 3 times the upper limit of normal.
7. Diagnosis of sleep apnea.
8. Brain metastases with signs or symptoms of increased intracranial pressure.
9. Inability to assess pain or response to pain medications for any reason, including psychiatric disorder, concurrent medical disorder, or concomitant therapy.
10. Has used methadone within 14 days of the Screening Visit.
11. Received an investigational study product(s) within 30 days of the Screening Visit.
12. Use of monoamine oxidase (MAO) inhibitors within 14 days of the Screening Visit.
18 Years
ALL
No
Sponsors
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INSYS Therapeutics Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Larry Dillaha, MD
Role: STUDY_DIRECTOR
Chief Medical Officer, Insys Therapeutics Inc
Locations
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Loma Linda, California, United States
Los Gatos, California, United States
San Mateo, California, United States
Bradenton, Florida, United States
Lake Worth, Florida, United States
Miami, Florida, United States
Winter Park, Florida, United States
Newnan, Georgia, United States
Chicago, Illinois, United States
Skokie, Illinois, United States
Zion, Illinois, United States
Elkhart, Indiana, United States
Bethesda, Maryland, United States
Southfield, Michigan, United States
Edina, Minnesota, United States
Jefferson City, Missouri, United States
Great Falls, Montana, United States
Kalispell, Montana, United States
Missoula, Montana, United States
Voorhees Township, New Jersey, United States
Flat Rock, North Carolina, United States
Winston-Salem, North Carolina, United States
Canton, Ohio, United States
Dayton, Ohio, United States
Eugene, Oregon, United States
Altoona, Pennsylvania, United States
Danville, Pennsylvania, United States
Lemoyne, Pennsylvania, United States
Kingsport, Tennessee, United States
Bellaire, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Port Sam Houston, Texas, United States
Tacoma, Washington, United States
Appleton, Wisconsin, United States
Oakville, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Ahmedabad, India, India
Bangalore, India, India
Bhopal, India, India
Hyderabad, India, India
Jaipur, India, India
Mumbai, India, India
Nashik, India, India
Pune, India, India
Huntsville, Alabama, United States
Winfield, Alabama, United States
Glendale, Arizona, United States
Scottsdale, Arizona, United States
Laguna Hills, California, United States
Countries
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Other Identifiers
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INS-06-007
Identifier Type: -
Identifier Source: org_study_id
NCT00589004
Identifier Type: -
Identifier Source: nct_alias