Osteoarthritis, KneePhase 2NCT00647231
HKT-500-US12 In Adult Patients With OA Knee Pain
A Phase 2 study testing HKT-500 Topical Patch in people with Osteoarthritis, Knee, run by Hisamitsu Pharmaceutical Co., Inc. at 29 sites in United States.
Trial summary
The objective of this study is to characterize the analgesic properties of single dose study of HKT-500 in subjects with pain caused by mild to moderate OA of the knee Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- HKT-500 Topical Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 29 sitesUnited States
- Study dates
- Mar 2008to Aug 2008
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female 45 years of age or older
- with osteoarthritis of the knee
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
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Hisamitsu Investigator Site
Austell, Georgia, 30106
Hisamitsu Investigator Site
Baton Rouge, Louisiana, 70809
Hisamitsu Investigator Site
Berlin, New Jersey, 08009
Hisamitsu Investigator Site
Birmingham, Alabama, 35209
Hisamitsu Investigator Site
Burbank, California, 91505
Hisamitsu Investigator Site
Chicago, Illinois, 60616
Hisamitsu Investigator Site
Cincinnati, Ohio, 45206
Hisamitsu Investigator Site
Colorado Springs, Colorado, 80909
Hisamitsu Investigator Site
DeLand, Florida, 32720
Hisamitsu Investigator Site
Duncansville, Pennsylvania, 16635
Hisamitsu Investigator Site
Escondido, California, 92025
Hisamitsu Investigator Site
Flint, Michigan, 48504
Hisamitsu Investigator Site
Hallandale, Florida, 33009
Hisamitsu Investigator Site
Houston, Texas, 77074
Hisamitsu Investigator Site
Lake Charles, Louisiana, 70601
Hisamitsu Investigator Site
Little Rock, Arkansas, 72205
Hisamitsu Investigator Site
Little Rock, Arkansas, 72211
Hisamitsu Investigator Site
Madisonville, Kentucky, 42431
Hisamitsu Investigator Site
Northridge, California, 91325
Hisamitsu Investigator Site
Ocala, Florida, 34474
Hisamitsu Investigator Site
Oklahoma City, Oklahoma, 73112
Hisamitsu Investigator Site
Omaha, Nebraska, 68114
Hisamitsu Investigator Site
Ormond Beach, Florida, 32174
Hisamitsu Investigator Site
Phoenix, Arizona, 85013
Hisamitsu Investigator Site
Raleigh, North Carolina, 27612
Hisamitsu Investigator Site
Salt Lake City, Utah, 84108
Hisamitsu Investigator Site
Savannah, Georgia, 31405
Hisamitsu Investigator Site
Stockbridge, Georgia, 30281
Hisamitsu Investigator Site
Zanesville, Ohio, 43701
About this study
Official title: Protocol HKT-500-US12: A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee
The objective of this study is to characterize the analgesic properties of single dose study of HKT-500 in subjects with pain caused by mild to moderate OA of the knee
Read the detailed description
A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects with Pain Caused by Mild to Moderate Osteoarthritis of the Knee
- Conditions
- Osteoarthritis, Knee
- Being tested
- HKT-500 Topical Patch, Placebo Patch
- Keywords
- Osteoarthritis,Knee,Ketoprofen,Pain,Patch,Analgesic
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HKT-500 Topical PatchDrug
Also called HKT-500, Ketoprofen
Treatment with Ketoprofen Topical Patch
Placebo PatchOther
Also called Sham tratment
Treatment with placebo patch
| Study group | Role | What they receive |
|---|---|---|
| A, 2, II, HKT-500 Topical Patch | Experimental | A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee Receives: Drug: HKT-500 Topical Patch |
| Placebo Patch | Placebo comparator | Treatment with placebo patch Receives: Other: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Onset and Duration
Measured: 36 hours
Secondary outcomes (1)
Outcome Time Frame
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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 2
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hisamitsu Pharmaceutical Co., Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenichi Furuta, Study director, Hisamitsu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647231
- Sponsor's protocol ID
- HKT-500-US12
- Status last verified
- May 2015
- First submitted
- 26 Mar 2008
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
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
- Protocol HKT-500-US12: A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00647231
- Acronym / sponsor ID
- HKT-500-US12
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis,Knee,Ketoprofen,Pain,Patch,Analgesic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hisamitsu Pharmaceutical Co., Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 31 Mar 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.
The objective of this study is to characterize the analgesic properties of single dose study of HKT-500 in subjects with pain caused by mild to moderate OA of the knee
Detailed description
A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects with Pain Caused by Mild to Moderate Osteoarthritis of the Knee
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, 2, II, HKT-500 Topical Patch | Experimental | Drug: HKT-500 Topical PatchA Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee |
| Placebo Patch | Placebo comparator | Other: Placebo PatchTreatment with placebo patch |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male or female 45 years of age or older
- with osteoarthritis of the knee
Key exclusion criteria (3 listed)
- subject is a woman of childbearing potential
- who has a positive urine pregnancy test,
- is lactating, or who is not surgically sterile
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 |
|---|---|---|
| HKT-500 Topical PatchAlso: HKT-500, KetoprofenTreatment with Ketoprofen Topical Patch | Drug | A, 2, II, HKT-500 Topical Patch |
| Placebo PatchAlso: Sham tratmentTreatment with placebo patch | Other | Placebo Patch |
Primary outcome
Time to Onset and Duration
Time frame: 36 hours
1 secondary outcome
Outcome Time Frame
Time frame: 36 hours
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.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Kenichi Furuta study director
Hisamitsu
29 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 HKT-500 Topical Patch in people with Osteoarthritis, Knee, run by Hisamitsu Pharmaceutical Co., Inc. at 29 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 3 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 29 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?
Time to Onset and Duration (time frame: 36 hours). 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.