Cancer, Pain
Conditions
Keywords
Pain Cancer, Chronic Pain
Brief summary
The purpose of this study is to evaluate the safety of the matrix fentanyl patch ZR-02-01 in providing relief of cancer pain.
Detailed description
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.
Interventions
ZR-02-01 patch contains fentanyl dispersed in a solid matrix, and will be available in 25, 50, 75 and 100 mcg/hr patches. The patches will be worn on the chest or upper arm and an overlay will be placed over the patch. Patches (and overlays) will be replaced every 3 days by the patient and/or responsible caregiver. If a patient experiences end-of-dose-failure, the dosing interval may be changed by the physician investigator to every 2 days. The maximum dose allowed in this study is 300 mcg/hr.
Sponsors
ZARS Pharma Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | 12 weeks | To evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe cancer pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 12 weeks | Patient's evaluation of pain intensity using the VAS (100 mm) |
| Global Satisfaction satisfied) | 12 weeks | Global Satisfaction using a 5-point Likert scale (0= not satisfied to 4 = completely satisfied) |
Countries
United States
Outcome results
None listed