Clinical trial NCT01901718: An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breakthrough Pain
Keywords: Breakthrough Pain
Subsys
Fentanyl
Opioid
Persistent Pain
Lead sponsor: International Clinical Research Institute
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Global Impression of Change
timeFrame: 30, 60, 90 days
Secondary outcomes:
measure: Percent of Patients Satisfied with Treatment
timeFrame: Baseline, 30, 60, 90 days
measure: Study Medication Ease of Use
timeFrame: Baseline, 30, 60, 90 days
measure: Quality of Life
timeFrame: Baseline, 30, 60, 90 days
measure: Assessment of Sleep
timeFrame: Baseline, 30, 60, 90 days
measure: Medication Dosing
timeFrame: Baseline
measure: Weight
timeFrame: Baseline, 30, 60, 90 days
measure: Blood Glucose
timeFrame: Baseline and 90 days
Other outcomes:
measure: Optimal Dose Calculation
timeFrame: 14 Days
Locations:
city: Overland Park
country: United States
facility: International Clinical Research Institute
state: Kansas
Study officials:
affiliation: International Clinical Research Institute
name: Srinivas Nalamachu, MD
role: PRINCIPAL_INVESTIGATOR
References: