Winston-Salem,
North Carolina
27103
Purpose:
The purpose of this study is to evaluate the safety of the matrix fentanyl patch ZR-02-01 in
providing relief of non-malignant chronic pain.
Study summary:
This study will evaluate the safety of the matrix fentanyl patch. The study will be
conducted in opioid-tolerant patients with moderate to severe non-malignant chronic pain
currently taking an around-the-clock opioid. Patients will discontinue their current opioid
regimen and begin using ZR-02-01 as soon as possible under the direction of the physician
investigator upon entry into the study. Patient's dose of ZR 02 01 will be determined by
the investigator using sponsor-provided conversion. Pain therapy will be under the
supervision of the physician investigator.
Criteria:
Inclusion Criteria:
- Patient is at least 18 and no older than 75 years of age
- Patient has moderate to severe, non-malignant chronic pain that is expected to last
for at least 12 months and is currently taking an around-the-clock opioid to treat
his/her pain
- Patient is already receiving opioid therapy, has demonstrated opioid tolerance, and
requires a total daily dose of opioids at least equivalent to 25 mcg/hr of
transdermal fentanyl. Patients who are considered opioid-tolerant are those who have
been taking a daily dose of at least 30 mg of oral morphine or morphine equivalent
opioid for at least 2 weeks.
Exclusion Criteria:
- Patient has active cancer
- Patient has a history of substance abuse or has a substance abuse disorder