Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain
Pain
About this trial
This is an interventional treatment trial for Pain focused on measuring Chronic Pain, Pain
Eligibility Criteria
Inclusion Criteria: Patient is 18 through 70 years of age. Patient has moderate to severe non-malignant chronic pain. Patient is opioid-tolerant, requires treatment with chronic opioids and is currently taking a dose of 50 mcg/hr transdermal fentanyl for the treatment of chronic pain. Patient must have been taking this dose for at least 2 weeks. Patient must be experiencing 1 to 4 episodes of target breakthrough pain (breakthrough pain that is related to the patient's chronic pain condition) a day while taking a dose of 50 mcg/hr transdermal fentanyl. Exclusion Criteria: Patient has active cancer. Patient has a history of substance abuse or has a substance abuse disorder. Patient is pregnant or breastfeeding.
Sites / Locations
- Arizona Reserach Center
- Florida's Institute of Clinical Research
- Drug Studies America
- Pain & Rehabilitation Clinic of Chicago
- Integrated Clinical Trial Services, Inc.
- Brigham & Women's Hospital
- Medical Advanced Pain Specialists
- Pain Management Associates
- Analgesic Development Ltd.
- Southeast Research Institute
- The Center for Clinical Research
- Pain Consultants of Oregon, PC
- Allegheny Pain Management
- Lifetree Clinical Research
- Advanced Pain Management
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
50 mcg/hr matrix fentanyl patch
Placebo Patch
active 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch (20 cm2)
placebo (20 cm2) will be indistinguishable in size, shape, and appearance to the active matrix fentanyl patch