Osteoarthritis of the KneePhase 3NCT00792727
HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain
A Phase 3 study testing ketoprofen Patch in people with Osteoarthritis of the Knee, run by Hisamitsu Pharmaceutical Co., Inc. at 36 sites in United States.
Trial summary
Ketoprofen in a topical patch formulation has been demonstrated to be effective for treating mild to moderate pain caused by various musculoskeletal disorders. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- ketoprofen Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 36 sitesUnited States
- Study dates
- Sep 2007to May 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- man or woman ≥45 years of age.
- clinical diagnosis of unilateral or bilateral OA of the knee
- taking an NSAID or acetaminophen on a regular basis and has a history of knee pain amelioration with NSAID or acetaminophen use.
- mild to moderate OA of the knee at the screening visit
- subject exhibits an arthritis "flare" in the target knee within 7 days day of withdrawing from a NSAID or acetaminophen.
- subject understands that treatment will be administered on an inpatient basis.
- subject is capable of understanding and complying with the protocol and has signed the informed consent document.
Who cannot join
- subject is a woman of childbearing potential who has a positive urine pregnancy test, is lactating, or who is not surgically sterile
- subject has symptoms that are attributable to primary inflammatory diseases of the joint
- subject has unstable knees including a history of the knee catching or giving way or physical examination evidence of instability
- subject has arthropathies that occur in conjunction with systemic diseases
- subject has a chronic pain condition
- subject is grossly obese
Show all 10Show fewer
- subject has a history of knee surgery within the past 12 months or arthroscopy within the past 6 months.
- subject has a history of osteotomies.
- subject is not willing to discontinue the use of NSAIDs, acetaminophen or other prohibited treatments
- subject used opioids for OA pain within 1 month
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Hisamitsu Investigator Site
Albuquerque, New Mexico, 87102
Hisamitsu Investigator Site
Anderson, South Carolina, 29621
Hisamitsu Investigator Site
Arlington, Virginia, 22205
Hisamitsu Investigator Site
Austin, Texas, 78752
Hisamitsu Investigator Site
Birmingham, Alabama, 35242
Hisamitsu Investigator Site
Bismarck, North Dakota, 58503
Hisamitsu Investigator Site
Chandler, Arizona, 85225
Hisamitsu Investigator Site
Charlottesville, Virginia, 22911
Hisamitsu Investigator Site
Cincinnati, Ohio, 45227
Hisamitsu Investigator Site
Colorado Springs, Colorado, 80910
Hisamitsu Investigator Site
Columbus, Ohio, 43212
Hisamitsu Investigator Site
Crestview Hills, Kentucky, 41017
Hisamitsu Investigator Site
Daytona Beach, Florida, 32117
Hisamitsu Investigator Site
Delray Beach, Florida, 33484
Hisamitsu Investigator Site
Denver, Colorado, 80204
Hisamitsu Investigator Site
Denver, Colorado, 80209
Hisamitsu Investigator Site
Evansville, Indiana, 47714
Hisamitsu Investigator Site
Fall River, Massachusetts, 02720
Hisamitsu Investigator Site
Fort Myers, Florida, 33916
Hisamitsu Investigator Site
Greensboro, North Carolina, 27401
Hisamitsu Investigator Site
Las Vegas, Nevada, 89104
Hisamitsu Investigator Site
Mogadore, Ohio, 44260
Hisamitsu Investigator Site
Newport News, Virginia, 23606
Hisamitsu Investigator Site
Oklahoma City, Oklahoma, 73109
Hisamitsu Investigator Site
Omaha, Nebraska, 68114
Hisamitsu Investigator Site
Pembroke Pines, Florida, 33024
Hisamitsu Investigator Site
Peoria, Arizona, 85381
Hisamitsu Investigator Site
Reno, Nevada, 89502
Hisamitsu Investigator Site
Salt Lake City, Utah, 84107
Hisamitsu Investigator Site
San Antonio, Texas, 78217
Hisamitsu Investigator Site
San Antonio, Texas, 78232
Hisamitsu Investigator Site
San Diego, California, 92108
Hisamitsu Investigator Site
Tulsa, Oklahoma, 74136
Hisamitsu Investigator Site
Warwick, Rhode Island, 02886
Hisamitsu Investigator Site
Yakima, Washington, 98902
Hisamitsu Investigator Site
Zanesville, Ohio, 43701
About this study
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Four-Week Study to Assess the Efficacy and Safety of HKT-500 in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee
Ketoprofen in a topical patch formulation has been demonstrated to be effective for treating mild to moderate pain caused by various musculoskeletal disorders.
Read the detailed description
The objective of this study is to demonstrate the short-term multiple dose efficacy and safety of HKT-500 in subjects with pain caused by mild to moderate osteoarthritis of the knee. The goal of the study is to gather additional information about the analgesic efficacy and safety of repeated, 24-hour applications of 2 HKT-500 patches per knee for a total of 28 days in subjects with pain caused by mild to moderate osteoarthritis of the knee.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- ketoprofen Patch, Placebo Patch
- Keywords
- Pain, Knee, Arthritis, Knee pain
- Medical subject headings
- Osteoarthritis, Knee, Pain, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketoprofen PatchDrug
Also called Ketoprofen topical patch
2 topical patches applied once daily for 28 days
Placebo PatchOther
Also called Sham Treatment
2 topical placebo patches applied once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Ketoprofen Patch | Experimental | Treatment with experimental drug Receives: Drug: ketoprofen Patch |
| Placebo Patch | Placebo comparator | Treatment with placebo drug Receives: Other: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline of the WOMAC pain subscale score at Visit 6 (Day 14 ± 2 days)
Measured: 14 days ± 2 days
Secondary outcomes (6)
WOMAC: Change from the baseline of the pain subscale score at Visit 5 (Day 7 ±1 day), Visit 7 (Day 21 ±3 days) and Visit 8 (Day 28 ±3 days)
Measured: 28 days (±3 days)
WOMAC: Change from the baseline of the subscale scores for stiffness and physical function at Visit 5, Visit 6, Visit 7 and Visit 8
Measured: 28 days (±3 days)
WOMAC: Change from the baseline of the composite score at Visit 5, Visit 6, Visit 7 and Visit 8
Measured: 28 days (±3 days)
Pain Intensity differences at rest, on motion and of overall assessment using a VAS scale at each follow-up assessments time point through Day 28.
Measured: 28 days
Subject's Global Assessment at Visit 6 and Visit 8
Measured: 28 days (±3 days)
Investigator's Global Assessment at Visit 6 and Visit 8
Measured: 28 days (±3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study startSep 2007
- Primary completionApr 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hisamitsu Pharmaceutical Co., Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mr. Kenichi Furuta, Study director, Hisamitsu Pharmaceutical Co., Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792727
- Sponsor's protocol ID
- HKT-500-US07
- Status last verified
- May 2015
- First submitted
- 14 Nov 2008
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Four-Week Study to Assess the Efficacy and Safety of HKT-500 in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00792727
- Acronym / sponsor ID
- HKT-500-US07
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Pain, Knee, Arthritis, Knee pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Hisamitsu Pharmaceutical Co., Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 18 Nov 2008 (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.
Ketoprofen in a topical patch formulation has been demonstrated to be effective for treating mild to moderate pain caused by various musculoskeletal disorders.
Detailed description
The objective of this study is to demonstrate the short-term multiple dose efficacy and safety of HKT-500 in subjects with pain caused by mild to moderate osteoarthritis of the knee. The goal of the study is to gather additional information about the analgesic efficacy and safety of repeated, 24-hour applications of 2 HKT-500 patches per knee for a total of 28 days in subjects with pain caused by mild to moderate osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketoprofen Patch | Experimental | Drug: ketoprofen PatchTreatment with experimental drug |
| Placebo Patch | Placebo comparator | Other: Placebo PatchTreatment with placebo drug |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- man or woman ≥45 years of age.
- clinical diagnosis of unilateral or bilateral OA of the knee
- taking an NSAID or acetaminophen on a regular basis and has a history of knee pain amelioration with NSAID or acetaminophen use.
- mild to moderate OA of the knee at the screening visit
- subject exhibits an arthritis "flare" in the target knee within 7 days day of withdrawing from a NSAID or acetaminophen.
Key exclusion criteria (10 listed)
- subject is a woman of childbearing potential who has a positive urine pregnancy test, is lactating, or who is not surgically sterile
- subject has symptoms that are attributable to primary inflammatory diseases of the joint
- subject has unstable knees including a history of the knee catching or giving way or physical examination evidence of instability
- subject has arthropathies that occur in conjunction with systemic diseases
- subject has a chronic pain condition
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 |
|---|---|---|
| ketoprofen PatchAlso: Ketoprofen topical patch2 topical patches applied once daily for 28 days | Drug | Ketoprofen Patch |
| Placebo PatchAlso: Sham Treatment2 topical placebo patches applied once daily for 28 days | Other | Placebo Patch |
Primary outcome
Change from the baseline of the WOMAC pain subscale score at Visit 6 (Day 14 ± 2 days)
Time frame: 14 days ± 2 days
6 secondary outcomes
WOMAC: Change from the baseline of the pain subscale score at Visit 5 (Day 7 ±1 day), Visit 7 (Day 21 ±3 days) and Visit 8 (Day 28 ±3 days)
Time frame: 28 days (±3 days)
WOMAC: Change from the baseline of the subscale scores for stiffness and physical function at Visit 5, Visit 6, Visit 7 and Visit 8
Time frame: 28 days (±3 days)
WOMAC: Change from the baseline of the composite score at Visit 5, Visit 6, Visit 7 and Visit 8
Time frame: 28 days (±3 days)
Pain Intensity differences at rest, on motion and of overall assessment using a VAS scale at each follow-up assessments time point through Day 28.
Time frame: 28 days
Subject's Global Assessment at Visit 6 and Visit 8
Time frame: 28 days (±3 days)
Investigator's Global Assessment at Visit 6 and Visit 8
Time frame: 28 days (±3 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 4 Jun 2015.
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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.
Mr. Kenichi Furuta study director
Hisamitsu Pharmaceutical Co., Inc.
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 ketoprofen Patch in people with Osteoarthritis of the Knee, run by Hisamitsu Pharmaceutical Co., 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 7 inclusion and 10 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 4 Jun 2015. 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?
Change from the baseline of the WOMAC pain subscale score at Visit 6 (Day 14 ± 2 days) (time frame: 14 days ± 2 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 4 Jun 2015.