PainPhase 2NCT00278824
Fentanyl Transdermal Patch With CHADD™ for Breakthrough Pain in Patients With Moderate to Severe Non-Malignant Pain
A Phase 2 study testing Matrix Transdermal Fentanyl/CHADD Drug Delivery System in people with Pain, run by ZARS Pharma Inc. at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain
- What is being tested?
- Matrix Transdermal Fentanyl/CHADD Drug Delivery System
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 15 sitesUnited States
- Study dates
- Jan 2006to Aug 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient has active cancer.
- Patient has a history of substance abuse or has a substance abuse disorder.
- Patient is pregnant or breastfeeding.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Allegheny Pain Management
Altoona, Pennsylvania, 16602
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Southeast Research Institute
Charlotte, North Carolina, 28203
Pain & Rehabilitation Clinic of Chicago
Chicago, Illinois, 60610
Pain Consultants of Oregon, PC
Eugene, Oregon, 97401
Pain Management Associates
Independence, Missouri, 64055
Florida's Institute of Clinical Research
Jacksonville, Florida, 32207
Drug Studies America
Marietta, Georgia, 30060
Medical Advanced Pain Specialists
Minneapolis, Minnesota, 55433
Analgesic Development Ltd.
New York, New York, 10022
Arizona Reserach Center
Phoenix, Arizona, 85023
Lifetree Clinical Research
Salt Lake City, Utah, 84106
Advanced Pain Management
Virginia Beach, Virginia, 23454
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, 50265
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
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
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Matrix Transdermal Fentanyl/CHADD Drug Delivery System, Placebo Patch
- Keywords
- Chronic Pain, Pain
- Medical subject headings
- Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matrix Transdermal Fentanyl/CHADD Drug Delivery SystemDrug
Also called ZR-02-01, Fentanyl Transdermal Matrix Patch
Patch applied every 3 days for 15 days
Placebo PatchDrug
Also called Placebo Matrix Patch
Placebo patch applied every 3 days for 15 days
| Study group | Role | What they receive |
|---|---|---|
| 50 mcg/hr matrix fentanyl patch | Experimental | active 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch (20 cm2) Receives: Drug: Matrix Transdermal Fentanyl/CHADD Drug Delivery System |
| Placebo Patch | Placebo comparator | placebo (20 cm2) will be indistinguishable in size, shape, and appearance to the active matrix fentanyl patch Receives: Drug: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 15, 20, 60 minutes
Secondary outcomes (4)
Adhesion assessment
An adhesion assessment will be conducted by the patient at each CHADD removal.
Measured: 3 days
Pain Relief
Patient's evaluation of pain relief using a 5-point verbal rating scale (VRS)
Measured: 15, 30, 60 minutes
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.
Measured: 60 minutes
Number of participants with adverse events
The frequency of adverse events, severity, and relationship to study drug was recorded.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionAug 2006
- Study completionAug 2006
Why it stopped: Difficulty identifying and enrolling eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZARS Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lynn R Webster, MD, Principal investigator, Lifetree Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278824
- Sponsor's protocol ID
- ZCM-201
- Status last verified
- Jun 2012
- First submitted
- 16 Jan 2006
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00278824
- Acronym / sponsor ID
- ZCM-201
- Conditions
- Pain
- Keywords
- Chronic Pain, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty identifying and enrolling eligible patients
- Enrolment
- 109 participants (actual)
- Lead sponsor
- ZARS Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 18 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 mcg/hr matrix fentanyl patch | Experimental | Drug: Matrix Transdermal Fentanyl/CHADD Drug Delivery Systemactive 50 mcg/hr ZR-02-01 matrix transdermal fentanyl patch (20 cm2) |
| Placebo Patch | Placebo comparator | Drug: Placebo Patchplacebo (20 cm2) will be indistinguishable in size, shape, and appearance to the active matrix fentanyl patch |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patient has active cancer.
- Patient has a history of substance abuse or has a substance abuse disorder.
- Patient is pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Matrix Transdermal Fentanyl/CHADD Drug Delivery SystemAlso: ZR-02-01, Fentanyl Transdermal Matrix PatchPatch applied every 3 days for 15 days | Drug | 50 mcg/hr matrix fentanyl patch |
| Placebo PatchAlso: Placebo Matrix PatchPlacebo patch applied every 3 days for 15 days | Drug | Placebo Patch |
Primary outcome
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.
Time frame: 0, 15, 20, 60 minutes
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.
4 secondary outcomes
Adhesion assessment
Time frame: 3 days
Pain Relief
Time frame: 15, 30, 60 minutes
Patient's Global Satisfaction Assessment
Time frame: 60 minutes
Number of participants with adverse events
Time frame: 15 days
Results and safety
The study was stopped early (reason given: Difficulty identifying and enrolling eligible patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn R Webster, MD principal investigator
Lifetree Clinical Research
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Matrix Transdermal Fentanyl/CHADD Drug Delivery System in people with Pain, run by ZARS Pharma Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty identifying and enrolling eligible patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 0, 15, 20, 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2012.