Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Moderate to Severe Cancer Pain

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Pain, Cancer

Intervention / Treatment
-----------------
* Drug: Fentanyl Transdermal Matrix Patch ZR-02-01


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZR-02-01<br>ZR-02-01 matrix transdermal fentanyl patch | Drug: Fentanyl Transdermal Matrix Patch ZR-02-01<br>* 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.<br>* Other names: ZR-02-01 matrix transdermal fentanyl patch;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | To evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe cancer pain | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Patient's evaluation of pain intensity using the VAS (100 mm) | 12 weeks | 
| Global Satisfaction satisfied) | Global Satisfaction using a 5-point Likert scale (0= not satisfied to 4 = completely satisfied) | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain Cancer, Chronic Pain