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

Stopped early

Conditions studied: Breakthrough Pain

In brief

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.

Key facts

Study ID

NCT01901718

Run by

International Clinical Research Institute

People needed

4

Starts

2013-04-01

Expected to finish

2014-01-01

Last updated by the study team

2014-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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