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

This study has been terminated.
(Based on PK data, product did not meet requirement for further development.)
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00126789
First received: August 2, 2005
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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 3

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

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    To evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe cancer pain


Secondary Outcome Measures:
  • Pain intensity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Patient's evaluation of pain intensity using the VAS (100 mm)

  • Global Satisfaction satisfied) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Global Satisfaction using a 5-point Likert scale (0= not satisfied to 4 = completely satisfied)


Enrollment: 24
Study Start Date: August 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZR-02-01
ZR-02-01 matrix transdermal fentanyl patch
Drug: Fentanyl Transdermal Matrix Patch ZR-02-01
ZR-02-01 patch contains fentanyl dispersed in a solid matrix, and will be available in 25, 50, 75 and 100 mcg/hr patches. The patches will be worn on the chest or upper arm and an overlay will be placed over the patch. Patches (and overlays) will be replaced every 3 days by the patient and/or responsible caregiver. If a patient experiences end-of-dose-failure, the dosing interval may be changed by the physician investigator to every 2 days. The maximum dose allowed in this study is 300 mcg/hr.
Other Name: ZR-02-01 matrix transdermal fentanyl patch

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126789

Locations
United States, California
Loma Linda Center for Pain Management
Loma Linda, California, United States, 92354
United States, North Carolina
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
ZARS Pharma Inc.
Investigators
Principal Investigator: Richard Rauck, MD The Center for Clinical Research
  More Information

No publications provided

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT00126789     History of Changes
Other Study ID Numbers: ZMF-301
Study First Received: August 2, 2005
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ZARS Pharma Inc.:
Pain Cancer
Chronic Pain

Additional relevant MeSH terms:
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 14, 2014