Ankle SprainPhase 3NCT00680784
HKT-500 in Adult Patients With Ankle Sprain
A Phase 3 study testing HKT-500 Ketoprofen Topical Patch in people with Ankle Sprain, run by Hisamitsu Pharmaceutical Co., Inc. at 30 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?
- HKT-500 Ketoprofen Topical Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 30 sitesUnited States
- Study dates
- Apr 2008to Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade I or Grade II Ankle Sprain.
Who cannot join
- The subject is a women of childbearing potential who has a positive urine pregnancy test, who is lactating, who is not surgically sterile (by tubal ligation or hysterectomy), or at least 2 years postmenopausal, and has not practice 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
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Hisamitsu Investigator Site.
Albuquerque, New Mexico, 87102
Hisamitsu Investigator Site.
Altoona, Pennsylvania, 16602
Hisamitsu Investigator Site.
Anaheim, California, 92804
Hisamitsu Investigator Site.
Bellevue, Washington, 98004
Hisamitsu Investigator Site.
Benzonia, Michigan, 49616
Hisamitsu Investigator Site.
Birmingham, Alabama, 35209
Hisamitsu Investigator Site.
Birmingham, Alabama, 35234
Hisamitsu Investigator Site.
Blue Ridge, Georgia, 30513
Hisamitsu Investigator Site.
Cadillac, Michigan, 49601
Hisamitsu Investigator Site.
Chicago, Illinois, 60616
Hisamitsu Investigator Site.
Colorado Springs, Colorado, 80909
Hisamitsu Investigator Site.
Fargo, North Dakota, 58103
Hisamitsu Investigator Site.
Feasterville, Pennsylvania, 19053
Hisamitsu Investigator Site.
Houston, Texas, 77074
Hisamitsu Investigator Site.
Interlochen, Michigan, 49643
Hisamitsu Investigator Site.
Kalamazoo, Michigan, 49009
Hisamitsu Investigator Site.
Kissimmee, Florida, 34741
Hisamitsu Investigator Site.
Montgomery, Alabama, 36106
Hisamitsu Investigator Site.
Morrisville, Pennsylvania, 19067
Hisamitsu Investigator Site.
New York, New York, 10022
Hisamitsu Investigator Site.
Norristown, Pennsylvania, 19401
Hisamitsu Investigator Site.
Oldsmar, Florida, 34677
Hisamitsu Investigator Site.
Omaha, Nebraska, 68114
Hisamitsu Investigator Site.
Paducah, Kentucky, 42003
Hisamitsu Investigator Site.
Pasadena, Maryland, 21122
Hisamitsu Investigator Site.
Pembroke Pines, Florida, 33026
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.
Zanesville, Ohio, 43701
About this study
Official title: Protocol HKT-500-US10: A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Grade I or Grade II 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
Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or older who have a painful, acute, benign, ankle sprain of the lateral ligament(s) within the previous 48 hours.
- Conditions
- Ankle Sprain
- Being tested
- HKT-500 Ketoprofen Topical Patch, Placebo Patch
- Keywords
- sprain, ankle, pain
- Medical subject headings
- Ankle Injuries, Sprains and Strains, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HKT-500 Ketoprofen Topical PatchDrug
Also called Ketoprofen Topical Patch
HKT-500 Ketoprofen Topical Patch
Placebo PatchOther
Also called Sham treatment
Placebo Patch
| Study group | Role | What they receive |
|---|---|---|
| HKT-500 Ketoprofen Topical Patch | Experimental | Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or older who have a painful, acute, benign, ankle sprain of the lateral ligament(s) within the previous 48 hours. Receives: Drug: HKT-500 Ketoprofen 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.
Pain Assessment
Measured: 2 Weeks
Secondary outcomes (1)
Safety Assessment
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2008
- Study completionNov 2008
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 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 Pharmaceutical Co., Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680784
- Sponsor's protocol ID
- HKT-500-US10
- Status last verified
- May 2015
- First submitted
- 16 May 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-US10: A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Grade I or Grade II Ankle Sprain
- ClinicalTrials.gov ID
- NCT00680784
- Acronym / sponsor ID
- HKT-500-US10
- Conditions
- Ankle Sprain
- Keywords
- sprain, ankle, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Hisamitsu Pharmaceutical Co., Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 20 May 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 demonstrate the multiple-dose efficacy and safety of HKT-500 for the treatment of ankle sprain.
Detailed description
Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or older who have a painful, acute, benign, ankle sprain of the lateral ligament(s) within the previous 48 hours.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HKT-500 Ketoprofen Topical Patch | Experimental | Drug: HKT-500 Ketoprofen Topical PatchRandomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or older who have a painful, acute, benign, ankle sprain of the lateral ligament(s) within the previous 48 hours. |
| Placebo Patch | Placebo comparator | Other: Placebo PatchTreatment with placebo patch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Grade I or Grade II Ankle Sprain.
Key exclusion criteria (1 listed)
- The subject is a women of childbearing potential who has a positive urine pregnancy test, who is lactating, who is not surgically sterile (by tubal ligation or hysterectomy), or at least 2 years postmenopausal, and has not practice 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 |
|---|---|---|
| HKT-500 Ketoprofen Topical PatchAlso: Ketoprofen Topical PatchHKT-500 Ketoprofen Topical Patch | Drug | HKT-500 Ketoprofen Topical Patch |
| Placebo PatchAlso: Sham treatmentPlacebo Patch | Other | Placebo Patch |
Primary outcome
Pain Assessment
Time frame: 2 Weeks
1 secondary outcome
Safety Assessment
Time frame: 2 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 4 Jun 2015.
Related trials for Ankle Sprain
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Ankle Sprain
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Enovis High Ankle Sprain Brace Testing
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
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 Pharmaceutical Co., Inc.
30 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 HKT-500 Ketoprofen Topical Patch in people with Ankle Sprain, run by Hisamitsu Pharmaceutical Co., Inc. at 30 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 30 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?
Pain Assessment (time frame: 2 Weeks). 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.