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

Sponsor:	ZARS Pharma Inc.
Information provided by:	ZARS Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00126789

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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:

MedlinePlus related topics: Cancer

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:

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:

To document pain intensity, global satisfaction and disease specific measures of health in patients with moderate to severe cancer pain being treated with the ZR-02-01 matrix transdermal fentanyl patch

Estimated Enrollment:	200
Study Start Date:	August 2005

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

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
United States, Utah
Cache Valley Cancer Treatment
Logan, Utah, United States, 84341

Sponsors and Collaborators

ZARS Pharma Inc.

More Information

No publications provided

Study ID Numbers:	ZMF-301
Study First Received:	August 2, 2005
Last Updated:	January 3, 2008
ClinicalTrials.gov Identifier:	NCT00126789 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by ZARS Pharma Inc.:

Pain Cancer
Chronic Pain

Additional relevant MeSH terms:

Anesthetics, Intravenous
Fentanyl
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 04, 2010