Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain

Completed · Phase 3

Conditions studied: Cancer, Pain

In brief

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.

Key facts

Study ID

NCT00538863

Run by

INSYS Therapeutics Inc

People needed

319

Starts

2007-12-01

Expected to finish

2010-10-01

Last updated by the study team

2013-10-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Study site — Winfield, Alabama, United States
• Study site — Glendale, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Laguna Hills, California, United States
• Study site — Loma Linda, California, United States
• Study site — Los Gatos, California, United States
• Study site — San Mateo, California, United States
• Study site — Bradenton, Florida, United States
• Study site — Lake Worth, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Newnan, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Skokie, Illinois, United States
• Study site — Zion, Illinois, United States
• Study site — Elkhart, Indiana, United States
• Study site — Bethesda, Maryland, United States
• Study site — Southfield, Michigan, United States
• Study site — Edina, Minnesota, United States
• Study site — Jefferson City, Missouri, United States
• Study site — Great Falls, Montana, United States
• Study site — Kalispell, Montana, United States
• Study site — Missoula, Montana, United States
• Study site — Voorhees Township, New Jersey, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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