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Trial record 25 of 56 for:    insys

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00538863
Recruitment Status : Completed
First Posted : October 3, 2007
Results First Posted : October 11, 2013
Last Update Posted : October 11, 2013
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Pain Drug: Fentanyl sublingual spray Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 319 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Open-label Multi-center Safety Trial of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain
Study Start Date : December 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Drug: Fentanyl sublingual spray
Fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, and 1600 µg

Experimental: 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.
Drug: Fentanyl sublingual spray
Fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, and 1600 µg

Primary Outcome Measures :
  1. Percentage of Patients That Experienced 1 or More Adverse Events [ Time Frame: Baseline to end of the study (up to 116 days) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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:

  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:

  1. Intolerable side effects to opioids or fentanyl.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00538863

Hide Hide 52 study locations
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United States, Alabama
Huntsville, Alabama, United States
Winfield, Alabama, United States
United States, Arizona
Glendale, Arizona, United States
Scottsdale, Arizona, United States
United States, California
Laguna Hills, California, United States
Loma Linda, California, United States
Los Gatos, California, United States
San Mateo, California, United States
United States, Florida
Bradenton, Florida, United States
Lake Worth, Florida, United States
Miami, Florida, United States
Winter Park, Florida, United States
United States, Georgia
Newnan, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Skokie, Illinois, United States
Zion, Illinois, United States
United States, Indiana
Elkhart, Indiana, United States
United States, Maryland
Bethesda, Maryland, United States
United States, Michigan
Southfield, Michigan, United States
United States, Minnesota
Edina, Minnesota, United States
United States, Missouri
Jefferson City, Missouri, United States
United States, Montana
Great Falls, Montana, United States
Kalispell, Montana, United States
Missoula, Montana, United States
United States, New Jersey
Voorhees, New Jersey, United States
United States, North Carolina
Flat Rock, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Canton, Ohio, United States
Dayton, Ohio, United States
United States, Oregon
Eugene, Oregon, United States
United States, Pennsylvania
Altoona, Pennsylvania, United States
Danville, Pennsylvania, United States
Lemoyne, Pennsylvania, United States
United States, Tennessee
Kingsport, Tennessee, United States
United States, Texas
Bellaire, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Port Sam Houston, Texas, United States
United States, Washington
Tacoma, Washington, United States
United States, Wisconsin
Appleton, Wisconsin, United States
Canada, Ontario
Oakville, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada
Quebec, Canada
Ahmedabad, India
Bangalore, India
Bhopal, India
Hyderabad, India
Jaipur, India
Mumbai, India
Nasik, India
Pune, India
Sponsors and Collaborators
INSYS Therapeutics Inc
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Study Director: Larry Dillaha, MD Chief Medical Officer, Insys Therapeutics Inc
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Responsible Party: INSYS Therapeutics Inc Identifier: NCT00538863    
Obsolete Identifiers: NCT00589004
Other Study ID Numbers: INS-06-007
First Posted: October 3, 2007    Key Record Dates
Results First Posted: October 11, 2013
Last Update Posted: October 11, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Cancer Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General