A Phase 3 interventional study of Esflurbiprofen Topical System (EFTS) in Contusions, sponsored by Teikoku Seiyaku Co., Ltd.. Completed at 5 sites in Germany. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-10-24.
Sponsored by Teikoku Seiyaku Co., Ltd. · Phase 3, Interventional, and Treatment
This study is an open-label, multi-centric clinical trial to evaluate the safety and efficacy of TK-254RX in patients with contusions. The primary objective of this study is to assess the safety of TK-254RX. Secondly objective is to evaluate the efficacy of contusions and adhesion of TK-254RX.
43 studies on the registry are indexed under Contusions; 8 are open to participants now.
This study's enrollment of 221 is above the median of 90 across 31 interventional studies indexed under Contusions.
Browse Contusions studies →Teikoku Seiyaku Co., Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
women of (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of defined as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Esflurbiprofen Topical System 165 mg Esflurbiprofen
Drug: Esflurbiprofen Topical System (EFTS)
One EFTS is applied to the injured area over 7 days
Recording adverse event and serious adverse event
Characterization of occurence of adverse events or serious adverse events of TK-254RX
Time frame: Day 1 to Day 8
100-mm Visual Analogue Scale (VAS) score on pain-on-movement (POM)
VAS score from no pain (0 mm) to worst pain (100 mm) on POM by a patient at each time point
Time frame: Day 1 to Day 8
100-mm Visual Analogue Scale (VAS) score on pain-at-rest (PAR)
VAS score from no pain (0 mm) to worst pain (100 mm) on PAR (at least 5 minutes rest) by a patient at each time point
Time frame: Day 1 to Day 8
Sum of Pain Intensity Difference (SPID) on pain-on-movement (POM)
Calculating the area under the curve for the difference of each pain intensity score by 100-mm-Visual Analogue Scale (VAS) on movement from the baseline over day 1 to day 8
Time frame: Day 1 to Day 8
Sum of Pain Intensity Difference (SPID) on pain-at-rest (PAR)
Calculating the area under the curve for the difference of each pain intensity score by 100-mm-Visual Analogue Scale (VAS) at rest from the baseline over day 1 to day 8
Time frame: Day 1 to Day 8
Pain Intensity Difference (PID) on pain-on movement (POM)
Difference of each pain intensity score by VAS on POM from the baseline at each time point
Time frame: Day 1 to Day 8
Pain Intensity Difference (PID) on pain-at-rest (PAR)
Difference of each pain intensity score by VAS on PAR form the baseline at each time point
Time frame: Day 1 to Day 8
Time to meaningful/optimal reduction
Time to meaningful/optimal reduction of pain defined as first at least 30% (meaningful) and 50% (optimal) reduction from baseline of VAS on POM
Time frame: Day 1 to Day 8
Time to complete resolution
* Time to complete resolution of POM VAS value of 0 mm * Time to complete resolution of PAR VAS value of 0 mm
Time frame: Day 1 to Day 8
Responder rate 1
Responder rate is defined as the number of patients achieving at least 50% reduction from baseline in the VAS scores for POM at 48 hours
Time frame: Day 3
Responder rate 2
number of patients able to resume training / normal physical activity by 168 hours
Time frame: Day 8
Resolution of contusion
The percentage of patients who showed POM=PAR=0 at 168 hours
Time frame: Day 8
Global efficacy assessments 1 by investigator
The global efficacy assessments are evaluated by the investigator as the response to the following questions: "Considering how this treatment has affected the patient since he/she started in the study, how well is he/she doing?" It is assessed on the following 5-point Likert scale: 0 = very good, 1 = good, 2 = fair, 3 = poor, 4 = very poor.
Time frame: Day 3, Day 4 and Day 8
Global efficacy assessments 2 by investigator
The global efficacy assessments are evaluated by the investigator as the response to the following questions: "How would you rate this medication for the treatment of this contution?" It is assessed on the following 5-point Likert scale: 0 = excellent, 1 = very good, 2 = good, 3 = moderate, 4 = poor.
Time frame: Day 3, Day 4 and Day 8
Global efficacy assessments 1 by patients
The global efficacy assessments are evaluated by the patients as the response to the following questions: "Considering how this treatment has affected you since you started in the study, how well are you doing?" It is assessed on the following 5-point Likert scale: 0 = very good, 1 = good, 2 = fair, 3 = poor, 4 = very poor.
Time frame: Day 3, Day 4 and Day 8
Global efficacy assessments 2 by patients
The global efficacy assessments are evaluated by the patients as the response to the following questions: "How do you rate this medication as a treatment for your contusion?" It is assessed on the following 5-point Likert scale: 0 = excellent, 1 = very good, 2 = good, 3 = fair, 4 = poor.
Time frame: Day 3, Day 4 and Day 8
Characterization of local tolerability
Assessing the local tolerability by using the 8-point dermal response (0: No evidence of irritation, 1: Minimal erythema, barely perceptible, 2: Definite erythema, readily visible, minimal edema or minimal papular response, 3: Erythema and papules, 4: Definite edema, 5: Erythema, edema, and papules, 6: Vesicular eruption, 7: Strong reaction spreading beyond test site) and other effects score (0: No other effect detected, A(0): Slightly glazed appearance, B(1): Markedly glazed appearance, C(2): Glazing with peeling and cracking, F(3): Glazing with fissures, G(3): Film of dried serous exudates covering all or part of the application site, H(3): Small petechial erosions and/or scabs) according to FDA recommendation
Time frame: Day 8
Number of use of rescue medication
Number of rescue medication use during clinical study
Time frame: Day 1 to Day 8
Patch adhesion assessed by the site staff
Adhesive power of the EFTS will be visually assessed and classified by the site staff in a 5-point-score (0=≥ 90% adhered / 1= ≥75% to \<90% adhered / 2=≥50% to \<75% adhered / 3=\>0% to \<50% adhered / 4=completely detached)
Time frame: Day 2 to Day 5
Patch adhesion assessed by patient
Adhesive power of the EFTS will be visually assessed and classified by a patient in a 5-point-score (0=≥ 90% adhered / 1= ≥75% to \<90% adhered / 2=≥50% to \<75% adhered / 3=\>0% to \<50% adhered / 4=completely detached)
Time frame: Day 1 to Day 8
Plan to share: No
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Ran from Feb 2025 to primary completion in Sep 2025, 7 months.
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Teikoku Seiyaku Co., Ltd.