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

ZARS Pharma

Status and phase

Terminated

Phase 3

Conditions

Cancer

Pain

Treatments

Drug: Fentanyl Transdermal Matrix Patch ZR-02-01

Study type

Interventional

Funder types

Industry

Identifiers

NCT00126789

ZMF-301

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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