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

August 2, 2005
June 4, 2012
August 2005
July 2007   (final data collection date for primary outcome measure)
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
To evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe cancer pain.
Complete list of historical versions of study NCT00126789 on ClinicalTrials.gov Archive Site
  • 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)
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.
Not Provided
Not Provided
 
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Moderate to Severe Cancer Pain
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

The purpose of this study is to evaluate the safety of the matrix fentanyl patch ZR-02-01 in providing relief of 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.

Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pain
  • Cancer
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
Experimental: ZR-02-01
ZR-02-01 matrix transdermal fentanyl patch
Intervention: Drug: Fentanyl Transdermal Matrix Patch ZR-02-01
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
July 2007
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00126789
ZMF-301
No
ZARS Pharma Inc.
ZARS Pharma Inc.
Not Provided
Principal Investigator: Richard Rauck, MD The Center for Clinical Research
ZARS Pharma Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP