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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


Phase 3
18 Years
75 Years
Not Enrolling
Both
Pain, Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of participants with adverse events

Outcome Description:

To evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe cancer pain

Outcome Time Frame:

12 weeks

Safety Issue:

Yes

Principal Investigator

Richard Rauck, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Center for Clinical Research

Authority:

United States: Food and Drug Administration

Study ID:

ZMF-301

NCT ID:

NCT00126789

Start Date:

August 2005

Completion Date:

July 2007

Related Keywords:

  • Pain
  • Cancer
  • Pain Cancer
  • Chronic Pain

Name

Location

The Center for Clinical ResearchWinston-Salem, North Carolina  27103
Loma Linda Center for Pain ManagementLoma Linda, California  92354