Clinical trial NCT00538863: Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain
Official title: Open-label Multi-center Safety Trial of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Pain
Lead sponsor: INSYS Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2007-10-03
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Patients That Experienced 1 or More Adverse Events
timeFrame: Baseline to end of the study (up to 116 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Winfield
country: United States
state: Alabama
city: Glendale
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Laguna Hills
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Los Gatos
country: United States
state: California
city: San Mateo
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Lake Worth
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Newnan
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Skokie
country: United States
state: Illinois
city: Zion
country: United States
state: Illinois
city: Elkhart
country: United States
state: Indiana
city: Bethesda
country: United States
state: Maryland
city: Southfield
country: United States
state: Michigan
city: Edina
country: United States
state: Minnesota
city: Jefferson City
country: United States
state: Missouri
city: Great Falls
country: United States
state: Montana
city: Kalispell
country: United States
state: Montana
city: Missoula
country: United States
state: Montana
city: Voorhees
country: United States
state: New Jersey
city: Flat Rock
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Eugene
country: United States
state: Oregon
city: Altoona
country: United States
state: Pennsylvania
city: Danville
country: United States
state: Pennsylvania
city: Lemoyne
country: United States
state: Pennsylvania
city: Kingsport
country: United States
state: Tennessee
city: Bellaire
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Port Sam Houston
country: United States
state: Texas
city: Tacoma
country: United States
state: Washington
city: Appleton
country: United States
state: Wisconsin
city: Oakville
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Quebec
country: Canada
city: Ahmedabad
country: India
city: Bangalore
country: India
city: Bhopal
country: India
city: Hyderabad
country: India
city: Jaipur
country: India
city: Mumbai
country: India
city: Nasik
country: India
city: Pune
country: India
Study officials:
affiliation: Chief Medical Officer, Insys Therapeutics Inc
name: Larry Dillaha, MD
role: STUDY_DIRECTOR
References: