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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538863
• Other study ID #: INS-06-007
• Status: Completed
• Phase: Phase 3
• First received: October 1, 2007
• Last updated: August 6, 2013
• Start date: December 2007
• Est. completion date: October 2010

Study information

• Verified date: August 2013
• Source: INSYS Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00589004

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
INSYS Therapeutics Inc

Countries where clinical trial is conducted

United States,  Canada,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients That Experienced 1 or More Adverse Events		Baseline to end of the study (up to 116 days)	Yes