PainPhase 2NCT00108771
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Osteoarthritis (OA) Pain
A Phase 2 study testing ZR-02-01 Fentanyl Transdermal Matrix Patch in people with Pain, run by ZARS Pharma Inc. at 13 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of the Matrix Fentanyl Patch ZR-02-01 in providing pain relief. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- ZR-02-01 Fentanyl Transdermal Matrix Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 13 sitesUnited States
- Study dates
- Apr 2004to Sep 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between the ages of 40 and 75 years of age suffering from moderate to severe chronic pain caused by osteoarthritis.
Who cannot join
- Patient is already taking chronic opioids or has a history of substance abuse or has a substance abuse disorder.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Pain Trials Center - Brigham & Women's Hospital
Boston, Massachusetts, 02115
Radiant Research
Daytona Beach, Florida, 32114
Phase III Clinical Trials
Fall River, Massachusetts, 02720
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119
Beth Israel Medical Center
New York, New York, 10003
Analgesic Development Ltd.
New York, New York, 10022
Ocala Rheumatology
Ocala, Florida, 34474
Arizona Reserach Center
Phoenix, Arizona, 85023
Redpoint Research
Phoenix, Arizona, 85029
Sharp Rees-Stealy Medical Group
San Diego, California, 92101
San Diego Arthritis Medical Clinic
San Diego, California, 92108
Tampa Medical Group
Tampa, Florida, 33614
Boling Clinical Trials
Upland, California, 91786
About this study
Official title: Double-Blind, Parallel, Randomized, Placebo-Controlled 12-Week Efficacy and Safety Assessment of ZR-02-01 in the Treatment of Chronic, Moderate to Severe Osteoarthritis (OA) Pain
The purpose of this study is to evaluate the effectiveness of the Matrix Fentanyl Patch ZR-02-01 in providing pain relief.
Read the detailed description
This study will evaluate the analgesic efficacy of the matrix fentanyl patch. The study will be conducted in non-opioid tolerant patients with moderate to severe osteoarthritis (OA) pain. This patient population was chosen in anticipation that the patients are otherwise healthy adults being treated with NSAIDs (Nonsteroidal Anti-inflammatory Drugs) or acetaminophen or who have received intermittent opioid analgesic treatment.
- Conditions
- Pain
- Being tested
- ZR-02-01 Fentanyl Transdermal Matrix Patch, Placebo Patch
- Keywords
- Pain, Chronic Pain, Osteoarthritis Pain, Osteoarthritis
- Medical subject headings
- Pain, Chronic Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZR-02-01 Fentanyl Transdermal Matrix PatchDrug
Also called ZR-02-01
Study patches were replaced every 72 hours and were to be applied on the upper chest or lateral aspect of the upper arms. The patch application sites were to be rotated so the patch was not applied to the same skin site for successive applications. Patients were supplied with Tegaderm if needed to keep the patches adhered during the 72 hour wear period.
Placebo PatchDrug
Also called Placebo Transdermal Matrix Patch
Study patches were replaced every 72 hours and were to be applied on the upper chest or lateral aspect of the upper arms. The patch application sites were to be rotated so the patch was not applied to the same skin site for successive applications. Patients were supplied with Tegaderm if needed to keep the patches adhered during the 72 hour wear period
| Study group | Role | What they receive |
|---|---|---|
| ZR-02-01 matrix fentanyl Patch | Experimental | ZR-02-01 matrix fentanyl patch Receives: Drug: ZR-02-01 Fentanyl Transdermal Matrix Patch |
| Placebo Patch | Placebo comparator | Not described Receives: Drug: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC Knee and Hip Osteoarthritis Index
The Pain,Stiffness and Physical Function subscales of the WOMAC Knee and Hip Osteoarthritis Index (5-point Likert scale: none through extreme) was employed. The subscales consist of 24 questions (5 pain, 2 stiffness and 17 physical function)
Measured: 12 weeks
Secondary outcomes (2)
Number of participants with adverse events
Measured: 12 weeks
TOPS survey
To document outcomes following pain therapy with ZR-02-01 using the TOPS survey, a disease-specific measure of health
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2005 (estimated)
- Study startApr 2004
- Primary completionSep 2006
- Study completionSep 2006
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZARS Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Farmer, Jr, MD, Principal investigator, Radiant Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108771
- Sponsor's protocol ID
- ZMF-202
- Status last verified
- Jun 2012
- First submitted
- 18 Apr 2005
- 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
- Double-Blind, Parallel, Randomized, Placebo-Controlled 12-Week Efficacy and Safety Assessment of ZR-02-01 in the Treatment of Chronic, Moderate to Severe Osteoarthritis (OA) Pain
- ClinicalTrials.gov ID
- NCT00108771
- Acronym / sponsor ID
- ZMF-202
- Conditions
- Pain
- Keywords
- Pain, Chronic Pain, Osteoarthritis Pain, Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- ZARS Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 19 Apr 2005 (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.
The purpose of this study is to evaluate the effectiveness of the Matrix Fentanyl Patch ZR-02-01 in providing pain relief.
Detailed description
This study will evaluate the analgesic efficacy of the matrix fentanyl patch. The study will be conducted in non-opioid tolerant patients with moderate to severe osteoarthritis (OA) pain. This patient population was chosen in anticipation that the patients are otherwise healthy adults being treated with NSAIDs (Nonsteroidal Anti-inflammatory Drugs) or acetaminophen or who have received intermittent opioid analgesic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZR-02-01 matrix fentanyl Patch | Experimental | Drug: ZR-02-01 Fentanyl Transdermal Matrix PatchZR-02-01 matrix fentanyl patch |
| Placebo Patch | Placebo comparator | Drug: Placebo Patch |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults between the ages of 40 and 75 years of age suffering from moderate to severe chronic pain caused by osteoarthritis.
Key exclusion criteria (1 listed)
- Patient is already taking chronic opioids or has a history of substance abuse or has a substance abuse disorder.
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 |
|---|---|---|
| ZR-02-01 Fentanyl Transdermal Matrix PatchAlso: ZR-02-01Study patches were replaced every 72 hours and were to be applied on the upper chest or lateral aspect of the upper arms. The patch application sites were to be rotated so the patch was not applied to the same skin site for successive applications. Patients were supplied with Tegaderm if needed to keep the patches adhered during the 72 hour wear period. | Drug | ZR-02-01 matrix fentanyl Patch |
| Placebo PatchAlso: Placebo Transdermal Matrix PatchStudy patches were replaced every 72 hours and were to be applied on the upper chest or lateral aspect of the upper arms. The patch application sites were to be rotated so the patch was not applied to the same skin site for successive applications. Patients were supplied with Tegaderm if needed to keep the patches adhered during the 72 hour wear period | Drug | Placebo Patch |
Primary outcome
WOMAC Knee and Hip Osteoarthritis Index
Time frame: 12 weeks
The Pain,Stiffness and Physical Function subscales of the WOMAC Knee and Hip Osteoarthritis Index (5-point Likert scale: none through extreme) was employed. The subscales consist of 24 questions (5 pain, 2 stiffness and 17 physical function)
2 secondary outcomes
Number of participants with adverse events
Time frame: 12 weeks
TOPS survey
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Frank Farmer, Jr, MD principal investigator
Radiant Research
13 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 ZR-02-01 Fentanyl Transdermal Matrix Patch in people with Pain, run by ZARS Pharma Inc. at 13 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 1 inclusion and 1 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: finished, 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 13 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
WOMAC Knee and Hip Osteoarthritis Index (time frame: 12 weeks). 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.