Acute Pain From Ankle Sprain or StrainPhase 3NCT02089425
An Efficacy and Safety Study for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain.
A Phase 3 study testing K-103-IP in people with Acute Pain From Ankle Sprain or Strain, run by Kowa Research Institute, Inc. at 47 sites in United States.
Trial summary
This is a randomized, double blind, placebo controlled, parallel group study to assess the efficacy and safety of K-103-IP compared with placebo patch for treatment of mild to moderate acute pain associated with ankle strain or sprain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Pain From Ankle Sprain or Strain
- What is being tested?
- K-103-IP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 384 participants
- Where
- 47 sitesUnited States
- Study dates
- Apr 2014to Dec 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must provide informed consent before any study specific evaluation is performed.
- Subject is male or female aged 18 to 70 years, inclusive.
- Subject has a grade 1 (mild functional impairment) or grade 2 (moderate functional impairment) ankle strain or sprain that occurred within 48 hours before the Screening visit.
- Subject has pain intensity upon monopodal weight bearing of 5 to 8, inclusive, measured by an 11 point nominal rating scale (NRS), plus pain intensity score at rest that is less than upon monopodal weight bearing.
Who cannot join
- Subject has a grade 3 (severe functional impairment) strain or sprain, bilateral strain or sprain, or concomitant fracture or wound at the site of the strain or sprain.
- Subject has had an ankle strain or sprain to the same foot within 6 months before the Screening visit.
- Subject has received topical analgesic medication within 24 hours before the Screening visit.
- Subject has applied ice or compression to the injured area within 2 hours before the Screening visit.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
United States47 sites
Study site
Anaheim, California
Study site
Atco, New Jersey
Study site
Austin, Texas
Study site
Birmingham, Alabama
Study site
Boerne, Texas
Study site
Bountiful, Utah
Study site
Boynton Beach, Florida
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Columbus, Ohio
Study site
Dayton, Ohio
Study site
Daytona Beach, Florida
Study site
Doral, Florida
Study site
El Cajon, California
Study site
El Paso, Texas
Study site
Encinitas, California
Study site
Great Falls, Montana
Study site
Gresham, Oregon
Study site
Hialeah, Florida
Study site
Houston, Texas
Study site
Jackson, Tennessee
Study site
Jacksonville, Florida
Study site
Kissimmee, Florida
Study site
Las Vegas, Nevada
Study site
Los Angeles, California
Study site
Memphis, Tennessee
Study site
Miami, Florida
Study site
Mooresville, North Carolina
Study site
Morganton, North Carolina
Study site
New York, New York
Study site
Oldsmar, Florida
Study site
Omaha, Nebraska
Study site
Orlando, Florida
Study site
Overland Park, Kansas
Study site
Owensboro, Kentucky
Study site
Phoenix, Arizona
Study site
Port Orange, Florida
Study site
Rapid City, South Dakota
Study site
Rochester, Michigan
Study site
Salt Lake City, Utah
Study site
Smyrna, Tennessee
Study site
St Louis, Missouri
Study site
Tempe, Arizona
Study site
Towson, Maryland
Study site
Ventura, California
Study site
Willoughby, Ohio
About this study
This is a randomized, double blind, placebo controlled, parallel group study to assess the efficacy and safety of K-103-IP compared with placebo patch for treatment of mild to moderate acute pain associated with ankle strain or sprain.
- Conditions
- Acute Pain From Ankle Sprain or Strain
- Being tested
- K-103-IP, Placebo
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-103-IPDrug
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo patch: 0% indomethacin Receives: Drug: Placebo |
| K-103-IP | Experimental | K-103-IP: 0.5% indomethacin Receives: Drug: K-103-IP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of Pain Intensity Difference(SPID) 0-72
Measured: 72 Hours
Secondary outcomes (1)
Mean change from Baseline in pain intensity difference (PID)
Measured: 168 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Interim futility analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pain From Ankle Sprain or StrainStudies 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
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Research Institute, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089425
- Sponsor's protocol ID
- K-103-IP-3.01US
- Status last verified
- Mar 2017
- First submitted
- 14 Mar 2014
- Last updated
- 3 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy and Safety Study for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain.
- ClinicalTrials.gov ID
- NCT02089425
- Acronym / sponsor ID
- K-103-IP-3.01US
- Conditions
- Acute Pain From Ankle Sprain or Strain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim futility analysis
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Kowa Research Institute, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Mar 2014 (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.
This is a randomized, double blind, placebo controlled, parallel group study to assess the efficacy and safety of K-103-IP compared with placebo patch for treatment of mild to moderate acute pain associated with ankle strain or sprain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo patch: 0% indomethacin |
| K-103-IP | Experimental | Drug: K-103-IPK-103-IP: 0.5% indomethacin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must provide informed consent before any study specific evaluation is performed.
- Subject is male or female aged 18 to 70 years, inclusive.
- Subject has a grade 1 (mild functional impairment) or grade 2 (moderate functional impairment) ankle strain or sprain that occurred within 48 hours before the Screening visit.
- Subject has pain intensity upon monopodal weight bearing of 5 to 8, inclusive, measured by an 11 point nominal rating scale (NRS), plus pain intensity score at rest that is less than upon monopodal weight bearing.
Key exclusion criteria (4 listed)
- Subject has a grade 3 (severe functional impairment) strain or sprain, bilateral strain or sprain, or concomitant fracture or wound at the site of the strain or sprain.
- Subject has had an ankle strain or sprain to the same foot within 6 months before the Screening visit.
- Subject has received topical analgesic medication within 24 hours before the Screening visit.
- Subject has applied ice or compression to the injured area within 2 hours before the Screening visit.
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 |
|---|---|---|
| K-103-IP | Drug | K-103-IP |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
Sum of Pain Intensity Difference(SPID) 0-72
Time frame: 72 Hours
1 secondary outcome
Mean change from Baseline in pain intensity difference (PID)
Time frame: 168 Hours
Results and safety
The study was stopped early (reason given: Interim futility analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
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.
47 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 K-103-IP in people with Acute Pain From Ankle Sprain or Strain, run by Kowa Research Institute, Inc. at 47 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 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 was stopped early (reason given: Interim futility analysis). Results are not available in the source record.
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?
Sum of Pain Intensity Difference(SPID) 0-72 (time frame: 72 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 3 Mar 2017.