Ankle SprainPhase 3NCT00927641
HKT-500 in the Treatment of Adult Patients With Ankle Sprain
A Phase 3 study testing Ketoprofen Patch in people with Ankle Sprain, run by Hisamitsu Pharmaceutical Co., Inc. at 25 sites in United States.
Trial summary
The objective of this study is to demonstrate the multiple-dose efficacy and safety of HKT-500 for the treatment of ankle sprain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Ketoprofen Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 25 sitesUnited States
- Study dates
- Jul 2009to Nov 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild to Moderate Ankle Sprain
Who cannot join
- Any women of childbearing potential who has a positive urine pregnancy test, who is lactating, who is not surgically sterile (by tubal ligation or hysterectomy), who is not at least 2 years postmenopausal, or has not practiced an acceptable form of birth control (defined as the use of an intrauterine device with spermicide, a barrier method with spermicide, condoms with spermicide, subdermal implant, oral contraceptives, or abstinence) for at least 2 months prior to Visit 1.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Hisamitsu Investigator Site
Anaheim, California, 92801
Hisamitsu Investigator Site
Anaheim, California, 92804
Hisamitsu Investigator Site
Birmingham, Alabama, 35290
Hisamitsu Investigator Site
Blackwood, New Jersey, 08012
Hisamitsu Investigator Site
Buena Park, California, 90620
Hisamitsu Investigator Site
Dallas, Texas, 75243
Hisamitsu Investigator Site
Danville, Virginia, 24541
Hisamitsu Investigator Site
Daytona Beach, Florida, 32117
Hisamitsu Investigator Site
Evansville, Indiana, 47714
Hisamitsu Investigator Site
Hialeah, Florida, 33013
Hisamitsu Investigator Site
Hot Springs, Arkansas, 71913
Hisamitsu Investigator Site
Jacksonville, Florida, 32216
Hisamitsu Investigator Site
Johnson City, Tennessee, 37604
Hisamitsu Investigator Site
Lauderdale Lakes, Florida, 33319
Hisamitsu Investigator Site
Long Beach, California, 90813
Hisamitsu Investigator Site
Oldsmar, Florida, 34677
Hisamitsu Investigator Site
Omaha, Nebraska, 68114
Hisamitsu Investigator Site
Ormond Beach, Florida, 32174
Hisamitsu Investigator Site
Phoenix, Arizona, 85050
Hisamitsu Investigator Site
San Diego, California, 92120
Hisamitsu Investigator Site
San Luis Obispo, California, 93405
Hisamitsu Investigator Site
South Bound Brook, New Jersey, 08880
Hisamitsu Investigator Site
South Miami, Florida, 33143
Hisamitsu Investigator Site
Tucson, Arizona, 85712
Hisamitsu Investigator Site
West Valley City, Utah, 84120
About this study
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Mild to Moderate Ankle Sprain
The objective of this study is to demonstrate the multiple-dose efficacy and safety of HKT-500 for the treatment of ankle sprain.
Read the detailed description
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Mild to Moderate Ankle Sprain
- Conditions
- Ankle Sprain
- Being tested
- Ketoprofen Patch, Placebo Patch
- Keywords
- Ankle Sprain
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketoprofen PatchDrug
Also called Topical Patch
Two Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days
Placebo PatchOther
Also called Sham treatment
Two placebo patches placed on target ankle once daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Ketoprofen Patch (HKT-500) | Active comparator | Two Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days Receives: Drug: Ketoprofen Patch |
| Placebo Patch | Placebo comparator | Two placebo patches placed on target ankle once daily for 14 days 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 100-mm VAS pain intensity score during monopodal weight bearing for 1 second at Visit 3 (Day 3 + 1 day)
Measured: 3 days + 1
Secondary outcomes (1)
Assessment of the subject's VAS pain intensity during monopodal weight bearing, at rest and in motion, summed pain intensity difference at rest and in motion, cumulative effect of pain reduction
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hisamitsu Pharmaceutical Co., Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927641
- Sponsor's protocol ID
- HKT-500-US17
- Status last verified
- May 2015
- First submitted
- 24 Jun 2009
- 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 Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Mild to Moderate Ankle Sprain
- ClinicalTrials.gov ID
- NCT00927641
- Acronym / sponsor ID
- HKT-500-US17
- Conditions
- Ankle Sprain
- Keywords
- Ankle Sprain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Hisamitsu Pharmaceutical Co., Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 25 Jun 2009 (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 demonstrate the multiple-dose efficacy and safety of HKT-500 for the treatment of ankle sprain.
Detailed description
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Mild to Moderate Ankle Sprain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketoprofen Patch (HKT-500) | Active comparator | Drug: Ketoprofen PatchTwo Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days |
| Placebo Patch | Placebo comparator | Other: Placebo PatchTwo placebo patches placed on target ankle once daily for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mild to Moderate Ankle Sprain
Key exclusion criteria (1 listed)
- Any women of childbearing potential who has a positive urine pregnancy test, who is lactating, who is not surgically sterile (by tubal ligation or hysterectomy), who is not at least 2 years postmenopausal, or has not practiced an acceptable form of birth control (defined as the use of an intrauterine device with spermicide, a barrier method with spermicide, condoms with spermicide, subdermal implant, oral contraceptives, or abstinence) for at least 2 months prior to Visit 1.
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: Topical PatchTwo Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days | Drug | Ketoprofen Patch (HKT-500) |
| Placebo PatchAlso: Sham treatmentTwo placebo patches placed on target ankle once daily for 14 days | Other | Placebo Patch |
Primary outcome
Change from the baseline of the 100-mm VAS pain intensity score during monopodal weight bearing for 1 second at Visit 3 (Day 3 + 1 day)
Time frame: 3 days + 1
1 secondary outcome
Assessment of the subject's VAS pain intensity during monopodal weight bearing, at rest and in motion, summed pain intensity difference at rest and in motion, cumulative effect of pain reduction
Time frame: 14 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.
The record lists no contact. Use the official record to reach the sponsor.
25 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 Ankle Sprain, run by Hisamitsu Pharmaceutical Co., Inc. at 25 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 1 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 25 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 100-mm VAS pain intensity score during monopodal weight bearing for 1 second at Visit 3 (Day 3 + 1 day) (time frame: 3 days + 1). 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.