An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray.

An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray Compared to Actiq® for the Management of Breakthrough Pain in Chronic Pain Patients.

Chronic pain patients who experience breakthrough pain in the background of controlled persistent pain with opioids will be followed for 3 months in order to assess the safety and titration trends in the clinical practice setting of a novel fentanyl sublingual spray (Subsys™) for the treatment of breakthrough pain.

Study Overview

• Status: Terminated
• Conditions: Breakthrough Pain

Detailed Description

Approximately 100 subjects across 10 centers throughout the United States will be enrolled into the study. Subjects who are currently taking Actiq® for their breakthrough pain and will be discontinued due to lack of efficacy, poor tolerability, patient or prescriber dissatisfaction and meet all other study inclusion criteria and none of the exclusion criteria will be candidates to receive a sublingual fentanyl spray (Subsys™). The total duration of the study for each subject will be no more than 4 months.

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • International Clinical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic pain patients who are opioid tolerant and who have failed Actiq® therapy for their breathrough pain will be prescribed Subsys™ fentanyl sublingual spray for their breakthrough pain.

Description

Inclusion Criteria:

• Patients ≥ 18 years of age.
• Subjects who are experiencing 1-4 episodes of break through pain per day in spite of optimized background analgesia and who have taken at least 60 mg/day of morphine (or equivalent analgesic) for at least 7 days.
• Who are currently using Actiq® for their breakthrough pain and are being discontinued due to lack of efficacy, side effects, patient dissatisfaction or prescriber dissatisfaction with treatment.
• Are able to follow and complete all necessary study procedures.
• Are willing and able to give written informed consent before participating in the study.
• Enrolled in the class wide REMS as verified by the study personnel.

Exclusion Criteria:

• Subjects who are not opioid tolerant.
• Using a rapid onset opioid other than Actiq® to manage their breakthrough pain.
• Have physical abnormalities of the floor of the mouth that could affect absorption as determined by investigator.
• Are subjects with uncontrolled or rapidly escalating pain.
• Are subjects with a history of alcohol or substance abuse within the last 3 years.
• Have a clinically significant medical history (past or present) of any disease that would compromise the study or the well-being of the subject.
• Are subjects who have participated in another clinical trial with an analgesic within the last month.
• Are female subjects with a positive pregnancy test or who are currently lactating.
• Are subjects who are taking medications that are known inhibitors of the CYP3A4 isozyme, such as ketoconazole.
• Are subjects who have taken a monoamine inhibitor within 14 days before a dose of study medication.
• Opioid being used for chronic migraine or acute pain.
• Are subjects who are unsuitable for inclusion for any other reason, in the opinion of the investigator.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Subsys; Cancer patients experiencing breakthrough pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Change	The overall impression of change based on a patient's response to the Patient Global Impression of Change (PGIC) questionnaire at month 1, 2, and 3 or upon early discontinuation.	30, 60, 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Patients Satisfied with Treatment	Patients will rate their treatment satisfaction using a 5-point scale ranging from 1= Very Dissatisfied to 5= Very Satisfied.	Baseline, 30, 60, 90 days
Study Medication Ease of Use		Baseline, 30, 60, 90 days
Quality of Life	Short Form 12 Question Health Survey Version 2 (SF-12v2) will be used to assess a subject's general quality of life.	Baseline, 30, 60, 90 days
Assessment of Sleep	Medical Outcomes Score (MOS) Sleep Subscale will be used to measures 6 dimensions of sleep and is a useful indicator of the efficacy of analgesic medications.	Baseline, 30, 60, 90 days
Medication Dosing	Equianalgesic dosing will be calculated based on subject's prior dose of Actiq® and final effective dose of Subsys™.	Baseline
Weight		Baseline, 30, 60, 90 days
Blood Glucose	Blood will be drawn to measure HbA1c.	Baseline and 90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal Dose Calculation	Time to "optimal" dose of an open-label study medication in the Titration phase.	14 Days

Collaborators and Investigators

• Sponsor: International Clinical Research Institute

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: April 25, 2013
• First Submitted That Met QC Criteria: July 15, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Estimate): September 4, 2014
• Last Update Submitted That Met QC Criteria: September 2, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Opioid; Fentanyl; Breakthrough Pain; Persistent Pain; Subsys
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Breakthrough Pain
• Other Study ID Numbers: ICRI-Subsys-001