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

Information source: ZARS Pharma Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain; Cancer

Intervention: Fentanyl Transdermal Matrix Patch ZR-02-01 (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: ZARS Pharma Inc.

Official(s) and/or principal investigator(s):
Richard Rauck, MD, Principal Investigator, Affiliation: The Center for Clinical Research

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.

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of participants with adverse events

Secondary outcome:

Pain intensity

Global Satisfaction satisfied)

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): 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

Locations and Contacts

Loma Linda Center for Pain Management, Loma Linda, California 92354, United States

The Center for Clinical Research, Winston-Salem, North Carolina 27103, United States

Additional Information

Starting date: August 2005
Last updated: June 4, 2012

Page last updated: August 23, 2015

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