A Phase 2 interventional study of Esflurbiprofen Hydrogel Patch in Soft Tissue Injuries, Contusions and Strains, sponsored by Teikoku Seiyaku Co., Ltd.. Completed at 1 site in Germany. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Teikoku Seiyaku Co., Ltd. · Phase 2, Interventional, and Treatment
Objective of this study is:
to determine efficacy and safety of a Esflurbiprofen Hydrogel Patch compared to placebo in patients with acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sports injuries.
to demonstrate that the Esflurbiprofen Hydrogel Patch is superior to placebo, and that the patch has acceptable local tolerability.
Study Design Randomized (1:1) (stratified by center and 2 subgroups), controlled, double-blind, multi-centric study in parallel groups. Patient Population/Sample size/Study Sites
The clinical trial population will consist of male or female patients, 18 - 60 years suffering from acute; strains, sprains or bruises of the extremities following blunt trauma, and meeting all clinical trial entry criteria.
200 patients will be enrolled (assumes a drop-out-rate of ≤10%).
The study will be performed in Germany in 3 sites
64 studies on the registry are indexed under Soft Tissue Injuries; 7 are open to participants now.
This study's enrollment of 200 is above the median of 60 across 51 interventional studies indexed under Soft Tissue Injuries.
Browse Soft Tissue Injuries 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.
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.
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
Drug: Esflurbiprofen Hydrogel Patch
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
Drug: Esflurbiprofen Hydrogel Patch
Esflurbiprofen is a cyclooxygenase (COX) inhibitor
Change of Pain-on-movement (POM) Compared to Baseline
Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Time frame: Change from baseline to Visit 5 (72 hours after initiating treatment)
Pain-on-movement (POM) on VAS
Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Time frame: Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment
Area-under-the-curve for POM on VAS
Area-under-the-curve (AUC) over time during first 12, 24, 48, 72, 96 and 168 hours for Pain on movement (POM) measured using a VAS Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Time frame: Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment
Pain-at-rest on VAS
Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Time frame: Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment
Time to Meaningful and Optimal Reduction
The time taken to achieve a meaningful (30 %) and optimal (50 %) reduction of pain measured on the VAS for POM Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Time frame: Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment
Time to Complete Resolution of Pain
Time to complete resolution of pain, i. e. reaching a POM VAS value of 0 mm after start of study treatment Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Time frame: Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment
Responder Rate 1
defined as the percentage of patients achieving ≥50% reduction from baseline in the VAS score for POM at 72 hours Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Time frame: 72 hours
Global Efficacy Assessments 1 by Patient
The global efficacy was assessed by the patients. The patients answered question below; -Considering all the ways this treatment has affected you since you started the clinical trial, how well are you doing? (5-point Likert scale: 0 = very good, 1 = good, 2 = fair, 3 = poor, and 4 = very poor). \[Global efficacy assessment 1\]
Time frame: 48 h, 72 h, and 168 h
Global Efficacy Assessments 2 by Patient
The global efficacy was assessed by the patients. The patients answered question below -How do you rate this medication as treatment for your soft injury/contusion? (5-point Likert scale: 0 = excellent, 1 = very good, 2 = good, 3 = fair, and 4 = poor). \[Global efficacy assessment 2\]
Time frame: 48 h, 72 h, and 168 h
Global Efficacy Assessments 1 by Investigator
The global efficacy was assessed by the investigator. -Considering all the ways this treatment has affected you since you started the clinical trial, how well are you doing? (5-point Likert scale: 0 = very good, 1 = good, 2 = fair, 3 = poor, and 4 = very poor). \[Global efficacy assessment 1\]
Time frame: 48 h, 72 h, and 168 h
Use of Rescue Medication
Rescue medication (paracetamol, 500 mg tablets, up to 3000 mg daily) was allowed during the study, except for the 6 hours prior to V5 (72 h).
Time frame: 0-168h
Resolution of Soft Tissue Injury/Contusion
Resolution of soft tissue injury/contusion was assessed by the Investigator at Visit 7 (168h).
Time frame: 168h
SPID of POM VAS Changes
The sum of pain intensity difference (SPID) of POM on VAS changes over 0-24 h, 0-48 h, 0-72 h, and 0-96 h were calculated. SPID was calculated as the area under the curve of the VAS difference from baseline value.
Time frame: 0-24 h, 0-48 h, 0-72 h, and 0-96 h
Responder Rate 2 at 168h
defined as the percentage of patients able to resume training/normal physical activity by 168 hours
Time frame: 168h
Adhesive Power of the Patch
Adhesive power of the patch measured by a 5 point numerical scale (0= ≥ 90 % adhered, 1= ≥ 75 % to \< 90 % adhered, 2= ≥ 50 % to \< 75 % adhered, 3= \> 0 % to \<50 % adhered, 4=completely detached) at every visit except V1.
Time frame: 12h for day 1, 24h for day 1-5 and 7 after application of each patch
Local Tolerability
Local tolerability was assessed by the Investigator according to the following numerical scale: 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
Time frame: 24, 48, 72, 96, 168h
| Milestone | Active Arm | Control Drug |
|---|---|---|
| Started | 98 | 102 |
| Completed | 98 | 102 |
| Not completed | 0 | 0 |
Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
| units on a scale | Active Arm | Control Drug |
|---|---|---|
| Change of Pain-on-movement (POM) Compared to Baseline | -50.7 ± 11.1 | -21.6 ± 11.9 |
Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
| units on a scale | Active Arm | Control Drug |
|---|---|---|
| Baseline | 69.9 ± 7.6 | 70.1 ± 8.3 |
| 12 hour | 61.1 ± 10.3 | 66.4 ± 8.4 |
| 24 hour | 48.8 ± 12.2 | 62.8 ± 10.4 |
| 48 hour | 33.3 ± 11.9 | 56.6 ± 12.0 |
| 72 hour | 19.2 ± 9.7 | 48.5 ± 14.9 |
| 96 hour | 9.2 ± 8.3 | 37.3 ± 16.7 |
| 168 hour | 2.1 ± 4.4 | 19.4 ± 17.4 |
Area-under-the-curve (AUC) over time during first 12, 24, 48, 72, 96 and 168 hours for Pain on movement (POM) measured using a VAS Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
| AUC of POM VAS pain (mm* h) | Active Arm | Control Drug |
|---|---|---|
| 0-12 h | 814.9 ± 107.0 | 842.9 ± 109.3 |
| 0-24 h | 1424.5 ± 210.3 | 1556.3 ± 182.6 |
| 0-48 h | 2397.3 ± 448.7 | 2970.3 ± 415.3 |
| 0-72 h | 3026.1 ± 655.8 | 4242.4 ± 730.3 |
| 0-96 h | 3367.6 ± 818.9 | 5300.7 ± 1166.8 |
| 0-168 h | 3771.4 ± 1149.6 | 7285.7 ± 1952.1 |
Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
| units on a scale | Active Arm | Control Drug |
|---|---|---|
| Baseline | 17.9 ± 5.9 | 17.0 ± 7.7 |
| 12 h | 14.7 ± 6.1 | 15.2 ± 6.4 |
| 24 h | 11.2 ± 5.4 | 13.5 ± 6.2 |
| 48 h | 7.5 ± 4.6 | 11.5 ± 6.2 |
| 72 h | 4.1 ± 3.4 | 9.2 ± 5.5 |
| 96 h | 2.0 ± 2.7 | 6.5 ± 5.4 |
| 168 h | 0.5 ± 1.5 | 3.7 ± 4.4 |
The time taken to achieve a meaningful (30 %) and optimal (50 %) reduction of pain measured on the VAS for POM Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
| Participants | Active Arm | Control Drug |
|---|---|---|
| Time to meaningful reduction of pain (h) (30% or more) — < 12 | 8 | 1 |
| Time to meaningful reduction of pain (h) (30% or more) — 12-24 | 41 | 3 |
| Time to meaningful reduction of pain (h) (30% or more) — 24-48 | 42 | 10 |
| Time to meaningful reduction of pain (h) (30% or more) — 48-72 | 7 | 33 |
| Time to meaningful reduction of pain (h) (30% or more) — 72-96 | 0 | 35 |
| Time to meaningful reduction of pain (h) (30% or more) — 96-192 | 0 | 15 |
| Time to meaningful reduction of pain (h) (30% or more) — Not achieved | 0 | 5 |
| Time to optimal reduction of pain (h) (50 % or more) — < 12 | 2 | 0 |
| Time to optimal reduction of pain (h) (50 % or more) — 12-24 | 4 | 1 |
| Time to optimal reduction of pain (h) (50 % or more) — 24-48 | 51 | 1 |
| Time to optimal reduction of pain (h) (50 % or more) — 48-72 | 36 | 13 |
| Time to optimal reduction of pain (h) (50 % or more) — 72-96 | 5 | 26 |
| Time to optimal reduction of pain (h) (50 % or more) — 96-192 | 0 | 42 |
| Time to optimal reduction of pain (h) (50 % or more) — Not achieved | 0 | 19 |
Time to complete resolution of pain, i. e. reaching a POM VAS value of 0 mm after start of study treatment Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
| Participants | Active Arm | Control Drug |
|---|---|---|
| 48-72h | 2 | 0 |
| 72-96h | 10 | 0 |
| 96-192h | 45 | 10 |
| Not achieved | 41 | 92 |
defined as the percentage of patients achieving ≥50% reduction from baseline in the VAS score for POM at 72 hours Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
| Participants | Active Arm | Control Drug |
|---|---|---|
| Responder Rate 1 | 93 | 15 |
The global efficacy was assessed by the patients. The patients answered question below; -Considering all the ways this treatment has affected you since you started the clinical trial, how well are you doing? (5-point Likert scale: 0 = very good, 1 = good, 2 = fair, 3 = poor, and 4 = very poor). \[Global efficacy assessment 1\]
| Participants | Active Arm | Control Drug |
|---|---|---|
| 48h — Very poor | 0 | 2 |
| 48h — Poor | 0 | 13 |
| 48h — Fair | 15 | 49 |
| 48h — Good | 47 | 30 |
| 48h — Very good | 36 | 8 |
| 72h — Very poor | 0 | 1 |
| 72h — Poor | 0 | 13 |
| 72h — Fair | 6 | 46 |
| 72h — Good | 41 | 31 |
| 72h — Very good | 51 | 11 |
| 168h — Very poor | 0 | 1 |
| 168h — Poor | 0 | 11 |
| 168h — Fair | 3 | 42 |
| 168h — Good | 36 | 31 |
| 168h — Very good | 59 | 17 |
The global efficacy was assessed by the patients. The patients answered question below -How do you rate this medication as treatment for your soft injury/contusion? (5-point Likert scale: 0 = excellent, 1 = very good, 2 = good, 3 = fair, and 4 = poor). \[Global efficacy assessment 2\]
| Participants | Active Arm | Control Drug |
|---|---|---|
| 48h — Poor | 0 | 11 |
| 48h — Fair | 12 | 35 |
| 48h — Good | 28 | 36 |
| 48h — Very good | 47 | 15 |
| 48h — Excellent | 11 | 5 |
| 72h — Poor | 0 | 13 |
| 72h — Fair | 7 | 36 |
| 72h — Good | 27 | 32 |
| 72h — Very good | 50 | 12 |
| 72h — Excellent | 14 | 9 |
| 168h — Poor | 0 | 12 |
| 168h — Fair | 7 | 29 |
| 168h — Good | 24 | 37 |
| 168h — Very good | 46 | 13 |
| 168h — Excellent | 21 | 11 |
The global efficacy was assessed by the investigator. -Considering all the ways this treatment has affected you since you started the clinical trial, how well are you doing? (5-point Likert scale: 0 = very good, 1 = good, 2 = fair, 3 = poor, and 4 = very poor). \[Global efficacy assessment 1\]
| Participants | Active Arm | Control Drug |
|---|---|---|
| 48h — Very poor | 0 | 1 |
| 48h — Poor | 1 | 20 |
| 48h — Fair | 15 | 45 |
| 48h — Good | 35 | 17 |
| 48h — Very good | 47 | 19 |
| 72h — Very poor | 0 | 0 |
| 72h — Poor | 0 | 22 |
| 72h — Fair | 8 | 46 |
| 72h — Good | 35 | 14 |
| 72h — Very good | 55 | 20 |
| 168h — Very poor | 0 | 1 |
| 168h — Poor | 0 | 19 |
| 168h — Fair | 8 | 42 |
| 168h — Good | 31 | 19 |
| 168h — Very good | 59 | 21 |
Rescue medication (paracetamol, 500 mg tablets, up to 3000 mg daily) was allowed during the study, except for the 6 hours prior to V5 (72 h).
| Participants | Active Arm | Control Drug |
|---|---|---|
| Use of Rescue Medication | 0 | 0 |
Resolution of soft tissue injury/contusion was assessed by the Investigator at Visit 7 (168h).
| Participants | Active Arm | Control Drug |
|---|---|---|
| Resolution of Soft Tissue Injury/Contusion | 92 | 49 |
The sum of pain intensity difference (SPID) of POM on VAS changes over 0-24 h, 0-48 h, 0-72 h, and 0-96 h were calculated. SPID was calculated as the area under the curve of the VAS difference from baseline value.
| SPID of POM on VAS (mm x h) | Active Arm | Control Drug |
|---|---|---|
| 0-24 h | 342.5 (-36 to 1003) | 126.6 (-86 to 518) |
| 0-48 h | 1211.1 (423 to 2346) | 445.9 (-75 to 1614) |
| 0-72 h | 2425.1 (1133 to 4122) | 965.5 (-51 to 2982) |
| 0-96 h | 3881.4 (2156 to 5970) | 1753.7 (21 to 4178) |
defined as the percentage of patients able to resume training/normal physical activity by 168 hours
| Participants | Active Arm | Control Drug |
|---|---|---|
| Responder Rate 2 at 168h | 92 | 49 |
Adhesive power of the patch measured by a 5 point numerical scale (0= ≥ 90 % adhered, 1= ≥ 75 % to \< 90 % adhered, 2= ≥ 50 % to \< 75 % adhered, 3= \> 0 % to \<50 % adhered, 4=completely detached) at every visit except V1.
| Number of patches | Active Arm | Control Drug |
|---|---|---|
| 12h — Completely detached | 1 | 0 |
| 12h — ≥ 0 % to < 50 % adhered | 0 | 4 |
| 12h — ≥ 50 % to < 75 % adhered | 23 | 27 |
| 12h — ≥ 75 % to < 90 % adhered | 46 | 51 |
| 12h — ≥ 90 % adhered | 28 | 20 |
| 24h — Completely detached | 0 | 1 |
| 24h — ≥ 0 % to < 50 % adhered | 10 | 10 |
| 24h — ≥ 50 % to < 75 % adhered | 101 | 145 |
| 24h — ≥ 75 % to < 90 % adhered | 202 | 206 |
| 24h — ≥ 90 % adhered | 177 | 148 |
Local tolerability was assessed by the Investigator according to the following numerical scale: 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
| Participants | Active Arm | Control Drug |
|---|---|---|
| 24h — Minimal erythema (1) | 3 | 4 |
| 24h — No evidence of irritation (0) | 95 | 98 |
| 48h — Minimal erythema (1) | 3 | 9 |
| 48h — No evidence of irritation (0) | 95 | 93 |
| 72h — Minimal erythema (1) | 4 | 6 |
| 72h — No evidence of irritation (0) | 94 | 96 |
| 96h — Minimal erythema (1) | 1 | 4 |
| 96h — No evidence of irritation (0) | 97 | 98 |
| 168h — Minimal erythema (1) | 4 | 4 |
| 168h — No evidence of irritation (0) | 94 | 98 |
Collected over From Baseline assessment for up to 7 days (±1 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Arm | 0/98 (0%) | 0/98 (0%) | 9/98 (9.2%) |
| Control Drug | 0/102 (0%) | 0/102 (0%) | 16/102 (15.7%) |
| Event | Active Arm | Control Drug |
|---|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 8/98 | 15/102 |
| InfectionInfections and infestations | 1/98 | 0/102 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 1/98 | 0/102 |
| Forearm fractureInjury, poisoning and procedural complications | 0/98 | 1/102 |
| Age, Continuous(years) | Active Arm | Control Drug | Total |
|---|---|---|---|
| Mean | 33.2 ± 11.0 | 34.3 ± 10.8 | 33.7 ± 10.9 |
| Sex: Female, Male(Participants) | Active Arm | Control Drug | Total |
|---|---|---|---|
| Female | 55 | 47 | 102 |
| Male | 43 | 55 | 98 |
| Ethnicity (NIH/OMB)(Participants) | Active Arm | Control Drug | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 60 | 64 | 124 |
| Unknown or Not Reported | 37 | 36 | 73 |
| Region of Enrollment(participants) | Active Arm | Control Drug | Total |
|---|---|---|---|
| Germany | 98 | 102 | 200 |
| Type of injury(Participants) | Active Arm | Control Drug | Total |
|---|---|---|---|
| Contusions | 73 | 72 | 145 |
| Sprains＆Strains | 25 | 30 | 55 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2021 to primary completion in Nov 2021, 5 months.
Results were first posted in Sep 2023, 1 year 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Teikoku Seiyaku Co., Ltd.