Ankle SprainPhase 4NCT01037816

FS-67 in the Treatment of Pediatric Patients With Ankle Sprain

A Phase 4 study testing FS-67 Patch in people with Ankle Sprain, run by Hisamitsu Pharmaceutical Co., Inc. at 23 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is assess the efficacy and safety of single and multiple applications of the FS-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17). Read more about this study

Who is it for?: Ages 13 to 17 years
Conditions the study is for: Ankle Sprain
What is being tested?: FS-67 Patch
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 252 participants
Where: 23 sitesUnited States
Study dates: Dec 2009to Dec 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 13 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Grade 1 or Grade 2 ankle sprain

Who cannot join

Pregnancy or lactation

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

United States23 sites

Hisamitsu Investigator Site
Anaheim, California, 92804
Hisamitsu Investigator Site
Bell Gardens, California, 90201
Hisamitsu Investigator Site
Bellevue, Nebraska, 68005
Hisamitsu Investigator Site
Berlin, New Jersey, 08009
Hisamitsu Investigator Site
Birmingham, Alabama, 35209
Hisamitsu Investigator Site
Boynton Beach, Florida, 33472
Hisamitsu Investigator Site
Charlotte, North Carolina, 28207
Hisamitsu Investigator Site
Columbus, Ohio, 43214
Hisamitsu Investigator Site
Dayton, Ohio, 45432
Hisamitsu Investigator Site
Daytona Beach, Florida, 32117
Hisamitsu Investigator Site
Doral, Florida, 33166
Hisamitsu Investigator Site
El Paso, Texas, 79902
Hisamitsu Investigator Site
Evansville, Indiana, 47714
Hisamitsu Investigator Site
Grapevine, Texas, 76051
Hisamitsu Investigator Site
Hot Springs, Arkansas, 71913
Hisamitsu Investigator Site
Jacksonville, Florida, 32216
Hisamitsu Investigator Site
Las Vegas, Nevada, 89106
Hisamitsu Investigator Site
Lincoln, Nebraska, 68510
Hisamitsu Investigator Site
Long Beach, California, 90806
Hisamitsu Investigator Site
Los Angeles, California, 90036
Hisamitsu Investigator Site
Topeka, Kansas, 66604
Hisamitsu Investigator Site
Tucson, Arizona, 85705
Hisamitsu Investigator Site
Tucson, Arizona, 85712

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain

The objective of this study is assess the efficacy and safety of single and multiple applications of the FS-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17).

Read the detailed description

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain

Conditions: Ankle Sprain
Being tested: FS-67 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.

FS-67 PatchDrug
Also called Topical Patch
One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Placebo PatchOther
Also called Sham treatment
One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)

Study groups in NCT01037816
Study group	Role	What they receive
FS-67 patch	Active comparator	One FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) Receives: Drug: FS-67 Patch
Placebo Patch	Placebo comparator	One placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days) Receives: Other: Placebo Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing.
Summed Pain Intensity Differences (SPID8) worst observation carried forward (WOCF) during monopodal weight-bearing on the affected ankle observed at specified time-points (1, 2, 4, 6, \& 8 hrs) after patch application. The SPID8 (WOCF) is a time-weighted sum of the pain intensity differences (PID), which were calculated as change from pain intensity at baseline to pain intensity at specified time points. Pain intensity was evaluated by means of a 100 mm visual analog scale (VAS), on which 0 mm represented no pain and 100 mm represented the worst pain imaginable. SPID8 was derived as the time-weighted sum (area under the curve) of the PID, where the weight assigned to each PID score is equal to the elapsed time (in hrs) since the previous scheduled evaluation time point. Five time-points were observed to calculate SPID8 therefore the potential SPID8 scores could range from -500 to +500 with negative values indicating increased pain over 8 hours.
Measured: 8 hours of patch application on Day 1

Secondary outcomes (1)

Sum of Pain Intensity Difference at 8-hours (SPID8) at Rest.
Summed Pain Intensity Differences (SPID8) worst observation carried forward (WOCF) at rest observed at specified time-points (1, 2, 4, 6, \& 8 hrs) after patch application. The SPID8 (WOCF) is a time-weighted sum of the pain intensity differences (PID), which were calculated as change from pain intensity at baseline to pain intensity at specified time points. Pain intensity was evaluated by means of a 100 mm visual analog scale (VAS), on which 0 mm represented no pain and 100 mm represented the worst pain imaginable. SPID8 was derived as the time-weighted sum (area under the curve) of the PID, where the weight assigned to each PID score is equal to the elapsed time (in hrs) since the previous scheduled evaluation time point. Five time-points were observed to calculate SPID8 therefore the potential SPID8 scores could range from -500 to +500 with negative values indicating increased pain over 8 hours.
Measured: 8 hours of patch application on Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Dec 2010

First posted23 Dec 2009 (estimated)
Study startDec 2009
Primary completionNov 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 252 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01037816
Sponsor's protocol ID: FS-67-HP01-E02
Status last verified: Sep 2022
First submitted: 18 Dec 2009
Last updated: 6 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
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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
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All Ankle Sprain trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With Ankle Sprain
ClinicalTrials.gov ID: NCT01037816
Acronym / sponsor ID: FS-67-HP01-E02
Conditions: Ankle Sprain
Keywords: Ankle Sprain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 252 participants (actual)
Lead sponsor: Hisamitsu Pharmaceutical Co., Inc.Industry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Nov 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 23 Dec 2009 (estimated)
Results: Posted 6 Oct 2022

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 assess the efficacy and safety of single and multiple applications of the FS-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17).

Detailed description

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of FS-67 Patches in Adolescent Subjects With 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
FS-67 patch	Active comparator	Drug: FS-67 PatchOne FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)
Placebo Patch	Placebo comparator	Other: Placebo PatchOne placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)

Who may qualify

Ages: 13 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Grade 1 or Grade 2 ankle sprain

Key exclusion criteria (1 listed)

Pregnancy or lactation

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
FS-67 PatchAlso: Topical PatchOne FS-67 patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)	Drug	FS-67 patch
Placebo PatchAlso: Sham treatmentOne placebo patch applied to target ankle every 12 hours for three days (up to 6 FS-67 patches in three days)	Other	Placebo Patch

Primary outcome

Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing.
Time frame: 8 hours of patch application on Day 1
Summed Pain Intensity Differences (SPID8) worst observation carried forward (WOCF) during monopodal weight-bearing on the affected ankle observed at specified time-points (1, 2, 4, 6, \& 8 hrs) after patch application. The SPID8 (WOCF) is a time-weighted sum of the pain intensity differences (PID), which were calculated as change from pain intensity at baseline to pain intensity at specified time points. Pain intensity was evaluated by means of a 100 mm visual analog scale (VAS), on which 0 mm represented no pain and 100 mm represented the worst pain imaginable. SPID8 was derived as the time-weighted sum (area under the curve) of the PID, where the weight assigned to each PID score is equal to the elapsed time (in hrs) since the previous scheduled evaluation time point. Five time-points were observed to calculate SPID8 therefore the potential SPID8 scores could range from -500 to +500 with negative values indicating increased pain over 8 hours.

1 secondary outcome

Sum of Pain Intensity Difference at 8-hours (SPID8) at Rest.
Time frame: 8 hours of patch application on Day 1

Results and safety

Results posted to the registry on 6 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FS-67 Patch	126	124
Placebo Patch	126	126

Primary outcome: Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing.

Time frame: 8 hours of patch application on Day 1. Least squares mean (Standard Error). Unit: units on a scale

Measure	FS-67 Patch n = 126	Placebo Patch n = 126
Value	107.19 (9.05)	89.13 (9.42)

FS-67 Patch vs Placebo Patch: p = 0.137, ANCOVA

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FS-67 Patch	0 of 126 (0%)	14 of 126 (11.1%)	0 of 126
Placebo Patch	0 of 126 (0%)	15 of 126 (11.9%)	0 of 126

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ankle Sprain

Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Recruiting
Enovis High Ankle Sprain Brace Testing
Athletes in Cutting Sports
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
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Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
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Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
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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.

Yoshinobu Higashi study director

Hisamitsu Pharmaceutical Co., Inc.

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FS-67 Patch in people with Ankle Sprain, run by Hisamitsu Pharmaceutical Co., Inc. at 23 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 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Primary: Sum of Pain Intensity Difference (SPID) at 8-hours (SPID8) Upon Monopodal Weight Bearing. (time frame: 8 hours of patch application on Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01037816.

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 6 Oct 2022.