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

Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00126789
• Other study ID #: ZMF-301
• Status: Terminated
• Phase: Phase 3
• First received: August 2, 2005
• Last updated: June 4, 2012
• Start date: August 2005
• Est. completion date: July 2007

Study information

• Verified date: June 2012
• Source: ZARS Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Loma Linda Center for Pain Management	Loma Linda	California
United States	The Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
ZARS Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events	To evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe cancer pain	12 weeks	Yes
Secondary	Pain intensity	Patient's evaluation of pain intensity using the VAS (100 mm)	12 weeks	No
Secondary	Global Satisfaction satisfied)	Global Satisfaction using a 5-point Likert scale (0= not satisfied to 4 = completely satisfied)	12 weeks	No