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.

Condition	Intervention	Phase
Pain	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, non-malignant chronic pain
Secondary Outcomes: To document pain intensity, global satisfaction and disease specific measures of health in patients with moderate to severe, non-malignant chronic 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 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.

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
• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00126763

Kansas
      Pain Management Institute, Overland Park,  Kansas,  66211,  United States; Recruiting
North Carolina
      The Center for Clinical Research, Winston Salem,  North Carolina,  27103,  United States; Recruiting

Study ID Numbers:  ZMF-303
Last Updated:  August 18, 2005
Record first received:  August 2, 2005
ClinicalTrials.gov Identifier:  NCT00126763
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23