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Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain

Primary Purpose

Pain

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Matrix Transdermal Fentanyl/CHADD Drug Delivery System
Placebo Patch
Sponsored by
ZARS Pharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Chronic Pain, Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient is 18 through 70 years of age. Patient has moderate to severe non-malignant chronic pain. Patient is opioid-tolerant, requires treatment with chronic opioids and is currently taking a dose of 50 mcg/hr transdermal fentanyl for the treatment of chronic pain. Patient must have been taking this dose for at least 2 weeks. Patient must be experiencing 1 to 4 episodes of target breakthrough pain (breakthrough pain that is related to the patient's chronic pain condition) a day while taking a dose of 50 mcg/hr transdermal fentanyl. Exclusion Criteria: Patient has active cancer. Patient has a history of substance abuse or has a substance abuse disorder. Patient is pregnant or breastfeeding.

Sites / Locations

  • Arizona Reserach Center
  • Florida's Institute of Clinical Research
  • Drug Studies America
  • Pain & Rehabilitation Clinic of Chicago
  • Integrated Clinical Trial Services, Inc.
  • Brigham & Women's Hospital
  • Medical Advanced Pain Specialists
  • Pain Management Associates
  • Analgesic Development Ltd.
  • Southeast Research Institute
  • The Center for Clinical Research
  • Pain Consultants of Oregon, PC
  • Allegheny Pain Management
  • Lifetree Clinical Research
  • Advanced Pain Management

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

50 mcg/hr matrix fentanyl patch

Placebo Patch

Arm Description

active 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch (20 cm2)

placebo (20 cm2) will be indistinguishable in size, shape, and appearance to the active matrix fentanyl patch

Outcomes

Primary Outcome Measures

Patient's rating of pain intensity (NRS), the patient's evaluation of pain relief using a 5-point verbal rating scale (VRS), and the patient's global satisfaction assessment.
Efficacy will be evaluated by the patient's rating of pain intensity using an 11-point numerical rating scale (NRS), the patient's evaluation of pain relief using a 5-point verbal rating scale (VRS), and the patient's global satisfaction assessment.

Secondary Outcome Measures

Adhesion assessment
An adhesion assessment will be conducted by the patient at each CHADD removal.
Pain Relief
Patient's evaluation of pain relief using a 5-point verbal rating scale (VRS)
Patient's Global Satisfaction Assessment
Patients completed a global satisfaction assessment 60 minutes after CHADD application. Patients were asked to assess their overall satisfaction with the CHADD throughout the 60 minute application period for the treatment of their breakthrough pain using the following 5-point scale: 0=not satisfied, 1=somewhat satisfied, 2=moderately satisfied, 3=very satisfied, and 4=completely satisfied.
Number of participants with adverse events
The frequency of adverse events, severity, and relationship to study drug was recorded.

Full Information

First Posted
January 16, 2006
Last Updated
June 4, 2012
Sponsor
ZARS Pharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00278824
Brief Title
Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain
Official Title
A Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy of CHADD™ Applied Over a Transdermal Fentanyl Patch for the Treatment of Breakthrough Pain in Patients With Moderate to Severe Non-malignant Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Difficulty identifying and enrolling eligible patients
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZARS Pharma Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A multi-center study to evaluate the efficacy of CHADD (Controlled Heat-Assisted Drug Delivery) applied over a 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch for the treatment of breakthrough pain in adult patients with moderate to severe non-malignant chronic pain. The open-label study arm will last up to 12 days. The double-blind arm will last up to 15 days. Eligible patients who complete the open-label arm will be allowed to enroll in the double-blind study arm.
Detailed Description
ZARS Pharma is developing a Matrix Transdermal Fentanyl/CHADD (Controlled Heat-Assisted Drug Delivery) Drug Delivery System to be used for the treatment of chronic and breakthrough pain. The Matrix Transdermal Fentanyl/CHADD Drug Delivery System has been designed to provide long-term delivery of fentanyl for the treatment of chronic pain as well as intermittent increases in fentanyl concentrations for the treatment of breakthrough pain. Breakthrough pain is defined as a transitory exacerbation of pain that occurs on a background of otherwise stable pain in a patient receiving chronic opioid therapy. Matrix Transdermal Fentanyl/CHADD Drug Delivery System has 2 components: a matrix transdermal fentanyl patch (the ZR-02-01 patch in doses of 25, 50, 75 and 100 mcg/hr) with corresponding thin film dressing (ie, overlay) and the CHADD (Controlled Heat-Assisted Drug Delivery). The matrix transdermal fentanyl patch provides a continuous delivery of fentanyl over 72 hours, in a manner similar to Duragesic®. During a breakthrough pain episode, a CHADD unit is placed over (adhered to) the matrix transdermal fentanyl patch. The CHADD is a thin patch-like chemical heating device that generates a controlled level of heat for approximately 15-20 minutes. The application of heat delivers increased amounts of fentanyl when applied over the ZR-02-01 matrix transdermal fentanyl patch.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Chronic Pain, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
50 mcg/hr matrix fentanyl patch
Arm Type
Experimental
Arm Description
active 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch (20 cm2)
Arm Title
Placebo Patch
Arm Type
Placebo Comparator
Arm Description
placebo (20 cm2) will be indistinguishable in size, shape, and appearance to the active matrix fentanyl patch
Intervention Type
Drug
Intervention Name(s)
Matrix Transdermal Fentanyl/CHADD Drug Delivery System
Other Intervention Name(s)
ZR-02-01, Fentanyl Transdermal Matrix Patch
Intervention Description
Patch applied every 3 days for 15 days
Intervention Type
Drug
Intervention Name(s)
Placebo Patch
Other Intervention Name(s)
Placebo Matrix Patch
Intervention Description
Placebo patch applied every 3 days for 15 days
Primary Outcome Measure Information:
Title
Patient's rating of pain intensity (NRS), the patient's evaluation of pain relief using a 5-point verbal rating scale (VRS), and the patient's global satisfaction assessment.
Description
Efficacy will be evaluated by the patient's rating of pain intensity using an 11-point numerical rating scale (NRS), the patient's evaluation of pain relief using a 5-point verbal rating scale (VRS), and the patient's global satisfaction assessment.
Time Frame
0, 15, 20, 60 minutes
Secondary Outcome Measure Information:
Title
Adhesion assessment
Description
An adhesion assessment will be conducted by the patient at each CHADD removal.
Time Frame
3 days
Title
Pain Relief
Description
Patient's evaluation of pain relief using a 5-point verbal rating scale (VRS)
Time Frame
15, 30, 60 minutes
Title
Patient's Global Satisfaction Assessment
Description
Patients completed a global satisfaction assessment 60 minutes after CHADD application. Patients were asked to assess their overall satisfaction with the CHADD throughout the 60 minute application period for the treatment of their breakthrough pain using the following 5-point scale: 0=not satisfied, 1=somewhat satisfied, 2=moderately satisfied, 3=very satisfied, and 4=completely satisfied.
Time Frame
60 minutes
Title
Number of participants with adverse events
Description
The frequency of adverse events, severity, and relationship to study drug was recorded.
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is 18 through 70 years of age. Patient has moderate to severe non-malignant chronic pain. Patient is opioid-tolerant, requires treatment with chronic opioids and is currently taking a dose of 50 mcg/hr transdermal fentanyl for the treatment of chronic pain. Patient must have been taking this dose for at least 2 weeks. Patient must be experiencing 1 to 4 episodes of target breakthrough pain (breakthrough pain that is related to the patient's chronic pain condition) a day while taking a dose of 50 mcg/hr transdermal fentanyl. Exclusion Criteria: Patient has active cancer. Patient has a history of substance abuse or has a substance abuse disorder. Patient is pregnant or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn R Webster, MD
Organizational Affiliation
Lifetree Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Reserach Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Florida's Institute of Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Pain & Rehabilitation Clinic of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Integrated Clinical Trial Services, Inc.
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Medical Advanced Pain Specialists
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Pain Management Associates
City
Independence
State/Province
Missouri
ZIP/Postal Code
64055
Country
United States
Facility Name
Analgesic Development Ltd.
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Southeast Research Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Pain Consultants of Oregon, PC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Allegheny Pain Management
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Advanced Pain Management
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain

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