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Overland Park, Kansas 66211

  • Pain

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.


Study summary:

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.


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


Study is Available At:


Original ID:

ZMF-303


NCT ID:

NCT00126763


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Terminated


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

ZARS Pharma Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

PK results suggested product did not meet re


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Interventi


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

105


Enrollment Type:

Actual


Overall Contact Information

Official Name:Richard Rauck, MD
Principal Investigator
The Center for Clinical Research

Study Dates

Start Date:July 2005
Completion Date:December 2006
Completion Type:Actual
Primary Completion Date:December 2006
Primary Completion Type:Actual
Verification Date:June 2012
Last Changed Date:June 4, 2012
First Received Date:August 2, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of participants with adverse eventsTo
Time Frame:12 months
Safety Issues:True
Description:Evaluate the safety of long-term administration of the ZR-02-01 patch for the treatment of moderate to severe, non-malignant chronic pain
Outcome Type:Secondary Outcome
Measure:Pain Intensity
Time Frame:12 months
Safety Issues:False
Description: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 o

Study Interventions

Intervention Type:Drug
Name:Fentanyl Transdermal Matrix Patch ZR-02-01
Description: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.
Arm Name:Matrix Transdermal Fentanyl Patch
Other Name:ZR-02-01

Study Arms

Study Arm Type:Experimental
Arm Name:Matrix Transdermal Fentanyl Patch

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:ZARS Pharma Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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