PainPhase 2NCT00108810
Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee
A Phase 2 study testing Transdermal Ketoprofen Patch with CHADD in people with Pain and Osteoarthritis, Knee, run by ZARS Pharma Inc. at 5 sites in United States.
Trial summary
The purpose of the study is to evaluate the safety and effectiveness of the investigational ketoprofen patch with a controlled heating patch, compared to placebo (inactive substance) for the treatment of pain caused by osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pain, Osteoarthritis, Knee
- What is being tested?
- Transdermal Ketoprofen Patch with CHADD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2005to Oct 2005
- 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
- Patient is between forty (40) and seventy-five (75) years of age.
- Patient has clinically diagnosed radiographic evidence of osteoarthritis of the knee within the past year.
Who cannot join
- Patient has known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication.
- Patient has a history of significant gastrointestinal disease or previous gastrointestinal upset following NSAID administration.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
SouthBay Pharma Research
Buena Park, California, 90620
Radiant Research
Daytona Beach, Florida, 32114
Hospital for Special Surgery
New York, New York, 10021
University Clinical Research
Pembroke Pines, Florida, 33024
The Center for Rheumatology and Bone Research
Washington D.C., District of Columbia, 20006
About this study
Official title: Randomized, Double-Blind, Parallel, Placebo Controlled 4 Week Proof-of-Concept Study to Evaluate the Safety and Efficacy of Transdermal Ketoprofen When Administered With Controlled Heat in Patients With Mild to Moderate OA Pain of the Knee
The purpose of the study is to evaluate the safety and effectiveness of the investigational ketoprofen patch with a controlled heating patch, compared to placebo (inactive substance) for the treatment of pain caused by osteoarthritis.
Read the detailed description
Proof-of-concept study, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of a transdermal ketoprofen patch with CHADD heat versus a placebo patch with dummy heat in patients with mild to moderate pain associated with osteoarthritis of the knee. After screening, patients discontinue all analgesic medication (except ≤325 mg aspirin daily for cardioprotective purposes). Patients selected a target knee (right or left), and all efficacy evaluations were completed with respect to this target knee. After discontinuing analgesics for at least 48 hours, and when the average pain intensity over the previous 24 hours for the target knee was ≥40 mm using a 100 mm visual analog scale (VAS), patients were randomized in a 1:1 fashion to receive treatment with either the transdermal ketoprofen patch with CHADD heat or the placebo patch with dummy heat. Patients treated the target knee each night for 12 hours (± 1 hour) for 4 weeks. Patients returned to the study site every 7 days (± 1 day) for study evaluations. Throughout the study, patients were allowed to take up to 2000 mg acetaminophen per day as rescue medication; however, rescue medication was not allowed within the 48 hours prior to efficacy evaluations.
- Conditions
- Pain, Osteoarthritis, Knee
- Being tested
- Transdermal Ketoprofen Patch with CHADD, Placebo transdermal patch
- Keywords
- Pain, Osteoarthritis, OA, Mild to Moderate Osteoarthritis (OA) Pain of the Knee
- Medical subject headings
- Pain, Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal Ketoprofen Patch with CHADDDrug
Also called Matrix Transdermal Ketoprofen/CHADD Sytem
12 hours patch application for 28 days
Placebo transdermal patchDrug
Also called Placebo patch with dummy heating unit
12 hours application for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Transdermal Ketoprofen Patch with CHADD | Experimental | Not described Receives: Drug: Transdermal Ketoprofen Patch with CHADD |
| Placebo patch and a dummy heating unit | Placebo comparator | Not described Receives: Drug: Placebo transdermal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the WOMAC pain subscale score
Measured: 28 days
Secondary outcomes (3)
Number of participants wih adverse events
Measured: 28 days
Patient Global Satisfaction score
Patient global satisfaction score at Study Visit 5
Measured: 28 days
Mean change from baseline for average pain over the last 24 hours VAS scores
Measured: 28 days
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 2005
- Primary completionOct 2005
- Study completionOct 2005
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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZARS Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Borenstein, MD, Principal investigator, The Center for RheumatologyH F Farmer, MD, Principal investigator, Radiant Research Inc.Larry Gilderman, DO, Principal investigator, University Clinical ResearchSoledad Lee, MD, Principal investigator, Southbay Pharma ResearchJoseph A Markenson, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108810
- Sponsor's protocol ID
- ZMK-202
- Status last verified
- May 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
- Randomized, Double-Blind, Parallel, Placebo Controlled 4 Week Proof-of-Concept Study to Evaluate the Safety and Efficacy of Transdermal Ketoprofen When Administered With Controlled Heat in Patients With Mild to Moderate OA Pain of the Knee
- ClinicalTrials.gov ID
- NCT00108810
- Acronym / sponsor ID
- ZMK-202
- Conditions
- Pain, Osteoarthritis, Knee
- Keywords
- Pain, Osteoarthritis, OA, Mild to Moderate Osteoarthritis (OA) Pain of the Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- ZARS Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (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 the study is to evaluate the safety and effectiveness of the investigational ketoprofen patch with a controlled heating patch, compared to placebo (inactive substance) for the treatment of pain caused by osteoarthritis.
Detailed description
Proof-of-concept study, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of a transdermal ketoprofen patch with CHADD heat versus a placebo patch with dummy heat in patients with mild to moderate pain associated with osteoarthritis of the knee. After screening, patients discontinue all analgesic medication (except ≤325 mg aspirin daily for cardioprotective purposes). Patients selected a target knee (right or left), and all efficacy evaluations were completed with respect to this target knee. After discontinuing analgesics for at least 48 hours, and when the average pain intensity over the previous 24 hours for the target knee was ≥40 mm using a 100 mm visual analog scale (VAS), patients were randomized in a 1:1 fashion to receive treatment with either the transdermal ketoprofen patch with CHADD heat or the placebo patch with dummy heat. Patients treated the target knee each night for 12 hours (± 1 hour) for 4 weeks. Patients returned to the study site every 7 days (± 1 day) for study evaluations. Throughout the study, patients were allowed to take up to 2000 mg acetaminophen per day as rescue medication; however, rescue medication was not allowed within the 48 hours prior to efficacy evaluations.
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 |
|---|---|---|
| Transdermal Ketoprofen Patch with CHADD | Experimental | Drug: Transdermal Ketoprofen Patch with CHADD |
| Placebo patch and a dummy heating unit | Placebo comparator | Drug: Placebo transdermal patch |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is between forty (40) and seventy-five (75) years of age.
- Patient has clinically diagnosed radiographic evidence of osteoarthritis of the knee within the past year.
Key exclusion criteria (2 listed)
- Patient has known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication.
- Patient has a history of significant gastrointestinal disease or previous gastrointestinal upset following NSAID administration.
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 |
|---|---|---|
| Transdermal Ketoprofen Patch with CHADDAlso: Matrix Transdermal Ketoprofen/CHADD Sytem12 hours patch application for 28 days | Drug | Transdermal Ketoprofen Patch with CHADD |
| Placebo transdermal patchAlso: Placebo patch with dummy heating unit12 hours application for 28 days | Drug | Placebo patch and a dummy heating unit |
Primary outcome
Change from baseline in the WOMAC pain subscale score
Time frame: 28 days
3 secondary outcomes
Number of participants wih adverse events
Time frame: 28 days
Patient Global Satisfaction score
Time frame: 28 days
Mean change from baseline for average pain over the last 24 hours VAS scores
Time frame: 28 days
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.
David Borenstein, MD principal investigator
The Center for Rheumatology
H F Farmer, MD principal investigator
Radiant Research Inc.
Larry Gilderman, DO principal investigator
University Clinical Research
5 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 Transdermal Ketoprofen Patch with CHADD in people with Pain and Osteoarthritis, Knee, run by ZARS Pharma Inc. at 5 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 2 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 5 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?
Change from baseline in the WOMAC pain subscale score (time frame: 28 days). 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.