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Open-label Multi-center Safety Trial of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain

Phase 3
18 Years
Not Enrolling
Cancer, Pain

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Trial Information

Open-label Multi-center Safety Trial of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain

This is an open-label multi-center study of the safety of Fentanyl SL Spray as a treatment
for breakthrough cancer pain. The study medication is administered under the tongue as a
simple spray and can be self-administered by subjects or assisted by their caregivers. In
addition, there is a questionnaire assessing satisfaction with the treatment. A total of
300 opioid-treated subjects will be enrolled.

Subjects may enter this study by one of two routes:

- De novo subjects who meet the inclusion criteria and none of the exclusion criteria at
the Screening Visit will enroll onto the study at the Open-label Titration Period;

- All subjects who have successfully completed the Double-blind Randomization Period and
the Final Visit of Protocol INS-05-001 will be eligible to enter this study as an
open-label extension study at the Open label Maintenance Period.

Inclusion Criteria:

All subjects who have completed the Double-blind period and final visit of protocol
INS-05-001, Multicenter Randomized Double-blind Trial of Fentanyl Sublingual Spray for the
Treatment of Breakthrough Cancer Pain are eligible for participation in INS-06-007 as an
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 mcg 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 one to four 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 (e.g., 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

4. Uncontrolled hypertension [systolic blood pressure (BP) >180 mmHg or diastolic BP >90
mmHg on two occasions at least six hours apart] despite antihypertensive therapy, or
has a history of hypertensive crisis within the past two years.

5. A recent history (within the past two years) of transient ischemic attacks, neural
vascular disease, stroke, or cerebral aneurysms.

6. Serum creatinine, ALT or AST that is greater than three times the upper limit of

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

The primary objective is to assess the safety of Fentanyl SL Spray in subjects on efficacious doses of Fentanyl SL Spray

Outcome Time Frame:

90 days

Safety Issue:


Principal Investigator

Larry Dillaha, MD

Investigator Role:

Study Director

Investigator Affiliation:

Chief Medical Officer, Insys Therapeutics Inc


United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

October 2010

Related Keywords:

  • Cancer
  • Pain



Multiple sites United States, California  00000