An Open-Label, Long-Term Safety Study to Evaluate the Safety of the ZR-02-01 Matrix Transdermal Fentanyl Patch for the Treatment of Moderate to Severe Cancer Pain
18 Years
75 Years
Both
Pain, Cancer
Trial Information
An Open-Label, Long-Term Safety Study to Evaluate the Safety of the ZR-02-01 Matrix Transdermal Fentanyl Patch for the Treatment of Moderate to Severe Cancer Pain
This study will evaluate the safety of the matrix fentanyl patch. The study will be
conducted in opioid-tolerant patients with moderate to severe cancer 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.
Inclusion Criteria:
- Patient is at least 18 and no older than 75 years of age at the time of screening
- Patient has a diagnosis of cancer
- Patient has moderate to severe pain that is related to cancer or its treatment and is
expected to last indefinitely and is currently taking an around-the-clock opioid to
treat his/her pain
- Patient is already receiving opioid therapy, has demonstrated opioid tolerance
- A responsible adult caregiver is available in the event of an emergency at home
Exclusion Criteria:
- Patient has uncontrolled or rapidly escalating pain as determined by the investigator
- Patient has a history of substance abuse or has a substance abuse disorder
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of participants with adverse events
Outcome Description:
To evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe cancer pain
Outcome Time Frame:
12 weeks
Safety Issue:
Yes
Principal Investigator
Richard Rauck, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Center for Clinical Research
Authority:
United States: Food and Drug Administration
Study ID:
ZMF-301
NCT ID:
NCT00126789
Start Date:
August 2005
Completion Date:
July 2007
Related Keywords:
- Pain
- Cancer
- Pain Cancer
- Chronic Pain
Name | Location |
|---|---|
| The Center for Clinical Research | Winston-Salem, North Carolina 27103 |
| Loma Linda Center for Pain Management | Loma Linda, California 92354 |
