Ankle SprainPhase 2NCT02729207
Proof-of-concept Study of NSAID Hydrogel Patch in Treatment of Acute Pain
A Phase 2 study testing Esflurbiprofen Hydrogel Patch in people with Ankle Sprain, run by Teikoku Seiyaku Co., Ltd. at 1 site in United States.
Trial summary
The safety and the efficacy of the Esflurbiprofen Hydrogel Patch will be assessed in comparing with placebo in the treatment of acute pain due to ankle sprain Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Esflurbiprofen Hydrogel Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 27 Dec 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be a male or female aged 18 to 65 years, inclusive.
- Subject must have a diagnosis of uncomplicated acute minor ankle sprain of Grade I or II as defined by the AAOS criteria.
- Ankle sprain must have occurred <48 hours prior to Screening.
- Subject must have a baseline self-evaluated pain score of >50 mm on a 100 mm VAS while bearing weight on the affected ankle.
- Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and be willing to use an acceptable form of birth control from the day of the first dose administration to 30 days after the last administration of the study product.
- Subject must be willing to refrain from using any other pain medication (other than allowed rescue medication) during their participation.
Who cannot join
- Subject is a pregnant, breastfeeding, or lactating female.
- Subject has an acute ankle sprain of Grade III as defined by AAOS criteria.
- Subject has an ankle fracture as confirmed by X-ray.
- Ankle sprain requires surgical treatment.
- Subject has experienced recurrent sprains (≥3 sprains of the same joint) or has sprained the affected joint within the last 12 months.
- Subject has taken analgesics other than NSAID(s) or acetaminophen for any purpose within 7 days of Screening.
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- Subject has taken flurbiprofen or naproxen within 24 hours of Screening.
- Ankle sprain is treated prior to Screening by ultrasound, physical therapy, or acupuncture.
- Subject has used immunomodulators or immunosuppressive therapies (e.g., interferon, oral or parenteral corticosteroids, and cytotoxic drugs) within 4 weeks prior to randomization.
- Subject has used any medicated topical agents (e.g., medicated creams or lotions) on the affected ankle within 7 days prior to Screening.
- Subject is currently using any other medications that, in the opinion of the Investigator, may exacerbate or mask the anticipated side effects of NSAIDs or interfere with the Investigator's ability to monitor for them (e.g., blood thinners or proton-pump inhibitors).
- Subject has non-intact or damaged skin in the area to be treated (e.g., eczema, psoriasis, exudative dermatitis, infected lesion, burn, or wound).
- Subject has a history of ulcers, GI bleeding, hypertension, edema, heart failure, or CV disease.
- Subject has asthma (except childhood asthma), urticaria, angioedema, or bronchospasm.
- a.A subject is eligible for the study if they have had no symptoms of these conditions that required medication in the 5 years prior to Screening.
- Subject has a history of any chronic pain disorder.
- Subject has coagulation defects.
- Subject has a history of severe cardiac, renal, or hepatic impairment within 12 months prior to Screening that, in the opinion of the Investigator, would interfere with the outcome of the study.
- Subject has a severe systemic disease (e.g., cancer or severe acute infection).
- Subject has a known allergy or hypersensitivity to flurbiprofen, aspirin, other NSAID(s), or any excipient in the IP.
- Subject has any systemic or dermatologic disorder that, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs.
- Subject has a history of uncontrolled chronic or acute concomitant disease that, in the Investigator's opinion, would contraindicate study participation or confound interpretation of the results.
- Subject has applied ice or compression to the affected ankle within 2 hours prior to Screening.
- Subject has a bilateral ankle injury.
- Subject has an ipsilateral knee injury. In the opinion of the Investigator, are unsuitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
SNBL Clinical Pharmacology Center
Baltimore, Maryland
About this study
Official title: A Phase II, Randomized, Double-blind, Placebo Controlled, Proof of Concept Study to Investigate the Safety and Efficacy of the Esflurbiprofen Hydrogel Patch in Treatment of Acute Pain Associated With Ankle Injury
The safety and the efficacy of the Esflurbiprofen Hydrogel Patch will be assessed in comparing with placebo in the treatment of acute pain due to ankle sprain
- Conditions
- Ankle Sprain
- Being tested
- Esflurbiprofen Hydrogel Patch
- Keywords
- NSAID Patch
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esflurbiprofen Hydrogel PatchDrug
One patch per day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Esflurbiprofen 1.5% Hydrogel Patch | Active comparator | One patch per 24hr for 7 days Receives: Drug: Esflurbiprofen Hydrogel Patch |
| Placebo comparator | Placebo comparator | Placebo One patch per 24hr for 7 days Receives: Drug: Esflurbiprofen Hydrogel Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of intensity of pain difference after 48hr treatment (SPID48h)
SPID48h will be compared between EFHP and placebo.
Measured: 48hr after treatment starting
Secondary outcomes (1)
SPID24h
Sum of intensity (VAS) of pain difference after 24hr
Measured: 24hr after treatment starting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startJul 2016
- Primary completion21 Dec 2016
- Study completion27 Dec 2016
Why it stopped: Due to lack of patients number
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teikoku Seiyaku Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masaru Kaneko, MD, Principal investigator, SNBL Clinical Pharmacology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729207
- Sponsor's protocol ID
- TS-TK-254-US0200
- Status last verified
- Oct 2021
- First submitted
- 31 Mar 2016
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Placebo Controlled, Proof of Concept Study to Investigate the Safety and Efficacy of the Esflurbiprofen Hydrogel Patch in Treatment of Acute Pain Associated With Ankle Injury
- ClinicalTrials.gov ID
- NCT02729207
- Acronym / sponsor ID
- TS-TK-254-US0200
- Conditions
- Ankle Sprain
- Keywords
- NSAID Patch
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of patients number
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Teikoku Seiyaku Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 27 Dec 2016 (actual)
- First posted
- 6 Apr 2016 (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 safety and the efficacy of the Esflurbiprofen Hydrogel Patch will be assessed in comparing with placebo in the treatment of acute pain due to ankle sprain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esflurbiprofen 1.5% Hydrogel Patch | Active comparator | Drug: Esflurbiprofen Hydrogel PatchOne patch per 24hr for 7 days |
| Placebo comparator | Placebo comparator | Drug: Esflurbiprofen Hydrogel PatchPlacebo One patch per 24hr for 7 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must be a male or female aged 18 to 65 years, inclusive.
- Subject must have a diagnosis of uncomplicated acute minor ankle sprain of Grade I or II as defined by the AAOS criteria.
- Ankle sprain must have occurred <48 hours prior to Screening.
- Subject must have a baseline self-evaluated pain score of >50 mm on a 100 mm VAS while bearing weight on the affected ankle.
- Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and be willing to use an acceptable form of birth control from the day of the first dose administration to 30 days after the last administration of the study product.
Key exclusion criteria (25 listed)
- Subject is a pregnant, breastfeeding, or lactating female.
- Subject has an acute ankle sprain of Grade III as defined by AAOS criteria.
- Subject has an ankle fracture as confirmed by X-ray.
- Ankle sprain requires surgical treatment.
- Subject has experienced recurrent sprains (≥3 sprains of the same joint) or has sprained the affected joint within the last 12 months.
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 |
|---|---|---|
| Esflurbiprofen Hydrogel PatchOne patch per day for 7 days | Drug | Esflurbiprofen 1.5% Hydrogel Patch, Placebo comparator |
Primary outcome
Sum of intensity of pain difference after 48hr treatment (SPID48h)
Time frame: 48hr after treatment starting
SPID48h will be compared between EFHP and placebo.
1 secondary outcome
SPID24h
Time frame: 24hr after treatment starting
Results and safety
The study was stopped early (reason given: Due to lack of patients number). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: No
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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
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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.
Masaru Kaneko, MD principal investigator
SNBL Clinical Pharmacology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Esflurbiprofen Hydrogel Patch in people with Ankle Sprain, run by Teikoku Seiyaku Co., Ltd. at 1 site 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 6 inclusion and 25 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 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Due to lack of patients number). 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 intensity of pain difference after 48hr treatment (SPID48h) (time frame: 48hr after treatment starting). 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 19 Oct 2021.