OsteoarthritisPhase 3NCT00532038
A Phase 3 Study to Evaluate the Long-Term Safety of ThermoProfen™ in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee.
A Phase 3 study testing ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System) in people with Osteoarthritis, run by ZARS Pharma Inc. at 20 sites in United States.
Trial summary
ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated with osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)
- How many people
- 179 participants
- Where
- 20 sitesUnited States
- Study dates
- Sep 2007to Nov 2008
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient completed a previous efficacy study of ThermoProfen.
Who cannot join
- Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin).
- Patient has a suspected hypersensitivity, allergy, or other contraindication to any compound present in the study medication or has a known sensitivity to adhesive components similar to those used in ThermoProfen (such as that found in adhesive bandages, e.g. Band-Aid®).
- Patient has asthma that has been induced or made worse by the use of aspirin or any other NSAID.
- Patient has a relevant history of serious gastrointestinal disease.
- Patient has a defect, injury, or dermatologic disease or condition on the skin area where the study patch will be applied that may interfere with tolerability or post-application evaluations.
- Patient has neurological or psychiatric disease sufficient to compromise data collection or integrity.
- Patient is taking warfarin, heparin, or low molecular weight heparin.
- Patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Study site
Anaheim, California, 92801
Study site
Anderson, South Carolina, 29621
Study site
Baltimore, Maryland, 21239
Study site
Clearwater, Florida, 33761
Study site
Duncansville, Pennsylvania, 16635
Study site
Erie, Pennsylvania, 16508
Study site
Evansville, Indiana, 47714
Study site
Houston, Texas, 77090
Study site
Kansas City, Missouri, 64114
Study site
Lake Oswego, Oregon, 97035
Study site
Mercerville, New Jersey
Study site
Nashville, Tennessee, 37205
Study site
Overland Park, Kansas, 66215
Study site
Pembroke Pines, Florida, 33024
Study site
Raleigh, North Carolina, 27612
Study site
San Antonio, Texas, 78217
Study site
San Diego, California, 92103
Study site
Springfield, Illinois, 62704
Study site
Westlake Village, California, 91361
Study site
Wheaton, Maryland, 20902
About this study
Official title: An Open-Label, Long-Term Safety Study to Evaluate the Safety of ThermoProfen™ for the Treatment of Mild to Moderate Pain Associated With Osteoarthritis of the Knee
ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated with osteoarthritis. This study will evaluate the safety of long-term administration of ThermoProfen™ for the pain associated with osteoarthritis of the knee in adults. The study will be conducted in patients with pain associated with osteoarthritis and who have completed a previous efficacy study of ThermoProfen.
Read the detailed description
The objective of the study is to evaluate the safety of long-term administration of ThermoProfen for the pain associated with osteoarthritis of the knee in adults.
- Conditions
- Osteoarthritis
- Being tested
- ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)
- Keywords
- Osteoarthritis, Pain
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)Drug
Patients will apply ThermoProfen daily for approximately 12 hours for up to 12 months for treatment of the pain associated with osteoarthritis of the knee.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of long-term administration of ThermoProfen™
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Corporate decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZARS Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, ZARS Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532038
- Sponsor's protocol ID
- ZMK-304
- Status last verified
- Mar 2012
- First submitted
- 18 Sep 2007
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Long-Term Safety Study to Evaluate the Safety of ThermoProfen™ for the Treatment of Mild to Moderate Pain Associated With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00532038
- Acronym / sponsor ID
- ZMK-304
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Corporate decision
- Enrolment
- 179 participants (actual)
- Lead sponsor
- ZARS Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 19 Sep 2007 (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.
ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated with osteoarthritis. This study will evaluate the safety of long-term administration of ThermoProfen™ for the pain associated with osteoarthritis of the knee in adults. The study will be conducted in patients with pain associated with osteoarthritis and who have completed a previous efficacy study of ThermoProfen.
Detailed description
The objective of the study is to evaluate the safety of long-term administration of ThermoProfen for the pain associated with osteoarthritis of the knee in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient completed a previous efficacy study of ThermoProfen.
Key exclusion criteria (8 listed)
- Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin).
- Patient has a suspected hypersensitivity, allergy, or other contraindication to any compound present in the study medication or has a known sensitivity to adhesive components similar to those used in ThermoProfen (such as that found in adhesive bandages, e.g. Band-Aid®).
- Patient has asthma that has been induced or made worse by the use of aspirin or any other NSAID.
- Patient has a relevant history of serious gastrointestinal disease.
- Patient has a defect, injury, or dermatologic disease or condition on the skin area where the study patch will be applied that may interfere with tolerability or post-application evaluations.
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 |
|---|---|---|
| ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)Patients will apply ThermoProfen daily for approximately 12 hours for up to 12 months for treatment of the pain associated with osteoarthritis of the knee. | Drug | – |
Primary outcome
To evaluate the safety of long-term administration of ThermoProfen™
Time frame: up to 12 months
Results and safety
The study was stopped early (reason given: Corporate decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 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.
Medical Monitor study director
ZARS Pharma
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System) in people with Osteoarthritis, run by ZARS Pharma Inc. at 20 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 8 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 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Corporate decision). 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?
To evaluate the safety of long-term administration of ThermoProfen™ (time frame: up to 12 months). 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 16 Mar 2012.