Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Non-Malignant Pain

This study has been terminated.
(PK results suggested product did not meet requirement for further development.)
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00126763
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 non-malignant chronic pain.


Condition Intervention Phase
Pain
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 Non-Malignant Chronic Pain

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • Number of participants with adverse eventsTo [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe, non-malignant chronic pain


Secondary Outcome Measures:
  • Pain Intensity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patient will rate pain intensity using a 100 mm VAS in which "0" equals "No Pain" and "100" equals "The Worst Pain You Can Imagine." Patients will be instructed on how to use the VAS and will base their response on the average pain that they experienced over the previous 24 hours. VAS will be collected at all study visits except screening.


Enrollment: 105
Study Start Date: July 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Matrix Transdermal Fentanyl Patch Drug: Fentanyl Transdermal Matrix Patch ZR-02-01
ZR-02-01 patch contains fentanyl dispersed in a solid matrix, and was available in 25, 50,75 and 100 mcg/hr patches. For patients who were using transdermal fentanyl (ie,Duragesic®), the initial dose of ZR-02-01 was the same as their current Duragesic dose. For patients who were taking oral opioids, the initial dose of ZR-02-01 was determined by the investigator using sponsor-provided conversion guidelines. The patches were worn on the chest or upper arm and an overlay was placed over the patch. Patches (and overlays) were replaced every 3 days
Other Name: ZR-02-01

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 non-malignant chronic 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
  • Patient has moderate to severe, non-malignant chronic pain that is expected to last for at least 12 months and is currently taking an around-the-clock opioid to treat his/her pain
  • Patient is already receiving opioid therapy, has demonstrated opioid tolerance, and requires a total daily dose of opioids at least equivalent to 25 mcg/hr of transdermal fentanyl. Patients who are considered opioid-tolerant are those who have been taking a daily dose of at least 30 mg of oral morphine or morphine equivalent opioid for at least 2 weeks.

Exclusion Criteria:

  • Patient has active cancer
  • 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: NCT00126763

Locations
United States, Arizona
Arizona Reserach Center
Phoenix, Arizona, United States, 85023
United States, California
Loma Linda Center for Pain Management
Loma Linda, California, United States, 92354
United States, Georgia
Drug Studies America
Marietta, Georgia, United States, 30060
United States, Kansas
Pain Management Institute
Overland Park, Kansas, United States, 66211
United States, Missouri
Pain Management Associates
Kansas City, Missouri, United States, 64137
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: NCT00126763     History of Changes
Other Study ID Numbers: ZMF-303
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.:
Chronic Pain
Pain

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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 August 01, 2014