The purpose of this study is to evaluate the safety of the matrix fentanyl patch ZR-02-01 in providing relief of cancer pain.

Condition	Intervention	Phase
Pain Cancer	Drug: Fentanyl Transdermal Matrix Patch ZR-02-01	Phase III

Further Study Details: 

Primary Outcomes: To evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe cancer pain
Secondary Outcomes: To document pain intensity, global satisfaction and disease specific measures of health in patients with moderate to severe cancer pain being treated with the ZR-02-01 matrix transdermal fentanyl patch
Expected Total Enrollment:  200

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.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00126789

Montana
      Big Sky Oncology, Great Falls,  Montana,  59405,  United States; Recruiting

Study ID Numbers:  ZMF-301
Last Updated:  August 19, 2005
Record first received:  August 2, 2005
ClinicalTrials.gov Identifier:  NCT00126789
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23