OsteoarthritisPhase 3NCT00488267

Efficacy 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 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 679 participants
Where: 36 sitesUnited States
Study dates: Jun 2007to Sep 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 is 18 through 75 years of age
Patient has radiographic evidence of osteoarthritis of the target knee obtained within the past year.

Who cannot join

Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs, including aspirin).
Patient has asthma that has been induced or made worse by the use of aspirin or NSAIDs.
Patient has a relevant history of serious gastrointestinal disease.
Patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.
Patient is taking warfarin, heparin, or low molecular weight heparin.
Patient has received oral, intramuscular, intravenous, intra-articular, or soft-tissue administration of steroids within 1 month of study enrollment (or within 2 months, if in the target joint).
Patient has received intra-articular visco-supplementation (in target joint) within 6 months of study enrollment.

Trial locations and contacts

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

United States36 sites

Study site
Anaheim, California, 92801
Study site
Anderson, South Carolina, 29621
Study site
Baltimore, Maryland, 21239
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Boise, Idaho, 83704
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Buena Park, California, 90620
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Clearwater, Florida, 33761
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Duncansville, Pennsylvania, 16635
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Erie, Pennsylvania, 16508
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Evansville, Indiana, 47714
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Greensboro, North Carolina, 27408
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Hamden, Connecticut, 06518
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Houston, Texas, 77090
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Jupiter, Florida, 33458
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Kansas City, Missouri, 64114
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Lake Oswego, Oregon, 97035
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Lansing, Michigan, 48910
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Mechanicsburg, Pennsylvania, 17055
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Mercerville, New Jersey, 08619
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Milford, Connecticut, 06460
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Myrtle Beach, South Carolina, 29572
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Nashville, Tennessee, 37205
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Overland Park, Kansas, 66215
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Pembroke Pines, Florida, 33024
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Peoria, Arizona, 85381
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Portland, Oregon, 97239
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Raleigh, North Carolina, 27612
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Salt Lake City, Utah, 84106
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San Antonio, Texas, 78217
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San Diego, California, 92103
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South Miami, Florida, 33143
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Spokane, Washington, 99204
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Springfield, Illinois, 62704
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Tacoma, Washington, 98405
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Tampa, Florida, 33614
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Westlake Village, California, 91361
Study site
Wheaton, Maryland, 20902

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, 12-Week Study to Evaluate the Efficacy of ThermoProfen™ in the Treatment of Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee (ZMK-301)

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 ThermoProfen for the treatment of mild to moderate pain associated with osteoarthritis of the knee in adults.

Read the detailed description

The primary objective of the study is to compare the efficacy of ThermoProfen™ against two other experimental treatments.

The treatment may be ThermoProfen (Matrix Transdermal Ketoprofen Patch) or a patch that may or may not include ketoprofen and that may or may not provide heat.

Conditions: Osteoarthritis
Being tested: ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System), Placebo Matrix/CHADD Patch, Ketoprofen matrix/placebo CHADD Patch
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
Also called Matrix Transdermal Ketoprofen CHADD System
Transdermal patch applied to the knee for 12 hours daily.
Placebo Matrix/CHADD PatchDrug
Also called Placebo patch with heating system
Transdermal patch applied to the knee for 12 hours daily.
Ketoprofen matrix/placebo CHADD PatchDrug
Also called ketoprofen matrix with no heat
Transdermal knee applied to the knee for 12 hours daily.

Study groups in NCT00488267
Study group	Role	What they receive
Thermoprofen	Experimental	ThermoProfen™ (ketoprofen matrix/Controlled Heat Assisted Drug Delivery [CHADD™] patch) Receives: Drug: ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)
Placebo Matrix	Placebo comparator	Placebo matrix with CHADD patch. Receives: Drug: Placebo Matrix/CHADD Patch
Ketoprofen matrix/placebo CHADD	Placebo comparator	Ketoprofen matrix with placebo CHADD patch (no heat) Receives: Drug: Ketoprofen matrix/placebo CHADD Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary outcome measure is the change from baseline in the Visual Analog Scale score for the average pain during the previous 24 hours.
Measured: 12 weeks

Secondary outcomes (1)

Change from baseline in Visual Analog Scale score for worst pain during the previous 24 hours, amount of rescue medication used to treat the target joint per day, and the patient global impression of change in the Likert Scale
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Sep 2008

First posted20 Jun 2007 (estimated)
Study startJun 2007
Primary completionJun 2008
Study completionSep 2008

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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 679 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00488267
Sponsor's protocol ID: ZMK-301
Status last verified: May 2012
First submitted: 18 Jun 2007
Last updated: 30 May 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, 12-Week Study to Evaluate the Efficacy of ThermoProfen™ in the Treatment of Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee (ZMK-301)
ClinicalTrials.gov ID: NCT00488267
Acronym / sponsor ID: ZMK-301
Conditions: Osteoarthritis
Keywords: Osteoarthritis, Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 679 participants (actual)
Lead sponsor: ZARS Pharma Inc.Industry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Jun 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 20 Jun 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.

Detailed description

The primary objective of the study is to compare the efficacy of ThermoProfen™ against two other experimental treatments.

The treatment may be ThermoProfen (Matrix Transdermal Ketoprofen Patch) or a patch that may or may not include ketoprofen and that may or may not provide heat.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Thermoprofen	Experimental	Drug: ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)ThermoProfen™ (ketoprofen matrix/Controlled Heat Assisted Drug Delivery [CHADD™] patch)
Placebo Matrix	Placebo comparator	Drug: Placebo Matrix/CHADD PatchPlacebo matrix with CHADD patch.
Ketoprofen matrix/placebo CHADD	Placebo comparator	Drug: Ketoprofen matrix/placebo CHADD PatchKetoprofen matrix with placebo CHADD patch (no heat)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patient is 18 through 75 years of age
Patient has radiographic evidence of osteoarthritis of the target knee obtained within the past year.

Key exclusion criteria (7 listed)

Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs, including aspirin).
Patient has asthma that has been induced or made worse by the use of aspirin or NSAIDs.
Patient has a relevant history of serious gastrointestinal disease.
Patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.
Patient is taking warfarin, heparin, or low molecular weight heparin.

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)Also: Matrix Transdermal Ketoprofen CHADD SystemTransdermal patch applied to the knee for 12 hours daily.	Drug	Thermoprofen
Placebo Matrix/CHADD PatchAlso: Placebo patch with heating systemTransdermal patch applied to the knee for 12 hours daily.	Drug	Placebo Matrix
Ketoprofen matrix/placebo CHADD PatchAlso: ketoprofen matrix with no heatTransdermal knee applied to the knee for 12 hours daily.	Drug	Ketoprofen matrix/placebo CHADD

Primary outcome

The primary outcome measure is the change from baseline in the Visual Analog Scale score for the average pain during the previous 24 hours.
Time frame: 12 weeks

1 secondary outcome

Change from baseline in Visual Analog Scale score for worst pain during the previous 24 hours, amount of rescue medication used to treat the target joint per day, and the patient global impression of change in the Likert Scale
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 30 May 2012.

Related trials for Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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

36 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 36 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 2 inclusion and 7 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 30 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 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 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 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?

The primary outcome measure is the change from baseline in the Visual Analog Scale score for the average pain during the previous 24 hours. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00488267.

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 30 May 2012.