An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray.
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/30/-0001 |
| Start Date: | April 2013 |
| Contact: | Christy Kuechler |
| Email: | christy@icrikansas.com |
| Phone: | 1-913-317-3500 |
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.
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.
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