Soft Tissue InjuriesPhase 2NCT04908748
Efficacy and Safety of Esflurbiprofen Hydrogel Patch in the Treatment of Local Acute Pain
A Phase 2 study testing Esflurbiprofen Hydrogel Patch in people with Soft Tissue Injuries and Contusions, run by Teikoku Seiyaku Co., Ltd. at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Soft Tissue Injuries, Contusions, Strains
- What is being tested?
- Esflurbiprofen Hydrogel Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 20 May 2021to 15 Dec 2021
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- acute sports-related soft-tissue injury/contusion (strains, sprains, bruises) of the upper or lower limb
- location of injury such that pain-on-movement (POM) is elicited on by specified exercises
- enrollment within 6 hours of the injury
- baseline VAS score for POM of injured extremity > 50 mm on a 100 mm VAS
- size of injury, as assessed by investigator, ≥ 25 cm2 and ≤ 120 cm2
- adult male or female patients
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- age 18 to 60 years
- having given written informed consent
- satisfactory health as determined by the Investigator based on medical history and physical examination.
Who cannot join
- significant concomitant injury in association with the index acute sports-related soft- tissue injury/contusion; e.g. fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound
- excessively hairy skin at application site, cutting the hair in the injured site prior to patch application will qualify for inclusion
- current skin disorder or shaving hair at application site
- history of excessive sweating/hyperhidrosis inclusive of application site
- intake of NSAIDs or analgesics within 36 hours, opioids within 7 days, or corticosteroids within 60 days of inclusion in the study
- intake of long-acting NSAIDs or application of topical medication since the injury (RICE allowed)
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- participation in a clinical study within 30 days before inclusion in the study or concomitantly
- drug or alcohol abuse in the opinion of the investigator
- Pregnant and lactating women
- Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:
- Surgical sterilization
- Hormonal contraception
- Intra Uterine Device
- Double barrier method
- Total abstinence throughout the study at the discretion of the Investigator.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Deutsche Sporthochschule Köln Institut für Kreislaufforschung und Sportmedizin
Cologne, North Rhine-Westphalia, 50933
About this study
Official title: The Efficacy and Safety of an Esflurbiprofen Hydrogel Patch vs. Placebo in the Local Symptomatic and Short-term Treatment of Pain in Acute Strains, Sprains or Bruises of the Extremities Following Blunt Trauma, e.g. Sports Injuries.
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.
Read the detailed description
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
- Conditions
- Soft Tissue Injuries, Contusions, Strains, Sprains, Bruises
- Being tested
- Esflurbiprofen Hydrogel Patch
- Keywords
- Blunt Trauma
- Medical subject headings
- Soft Tissue Injuries, Contusions, Sprains and Strains, Wounds, Nonpenetrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esflurbiprofen Hydrogel PatchDrug
Esflurbiprofen is a cyclooxygenase (COX) inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Experimental | Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen Receives: Drug: Esflurbiprofen Hydrogel Patch |
| Control Drug | Placebo comparator | Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch Receives: Drug: Esflurbiprofen Hydrogel Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain-on-movement (POM) Compared to Baseline
Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Measured: Change from baseline to Visit 5 (72 hours after initiating treatment)
Secondary outcomes (13)
Pain-on-movement (POM) on VAS
Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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]
Measured: 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]
Measured: 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]
Measured: 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).
Measured: 0-168h
Resolution of Soft Tissue Injury/Contusion
Resolution of soft tissue injury/contusion was assessed by the Investigator at Visit 7 (168h).
Measured: 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.
Measured: 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
Measured: 168h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start20 May 2021
- Primary completion9 Nov 2021
- Study completion15 Dec 2021
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 Soft Tissue InjuriesStudies 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
- Model description
- Randomized, controlled, double-blind, multi-center
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teikoku Seiyaku Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinSearch, CRM Biometrics GmbH, Clinigen, Inc.
- Responsible party
- Sponsor
- Investigators
- Hiroshi Aoki, Study chair, Teikoku Seiyaku Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908748
- Sponsor's protocol ID
- TK-254R-0201
- Status last verified
- Sep 2023
- First submitted
- 21 May 2021
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of an Esflurbiprofen Hydrogel Patch vs. Placebo in the Local Symptomatic and Short-term Treatment of Pain in Acute Strains, Sprains or Bruises of the Extremities Following Blunt Trauma, e.g. Sports Injuries.
- ClinicalTrials.gov ID
- NCT04908748
- Acronym / sponsor ID
- TK-254R-0201
- Conditions
- Soft Tissue Injuries, Contusions, Strains, Sprains, Bruises
- Keywords
- Blunt Trauma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Teikoku Seiyaku Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- ClinSearch, CRM Biometrics GmbH, Clinigen, Inc.
- Study start
- 20 May 2021 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, double-blind, multi-center
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Experimental | Drug: Esflurbiprofen Hydrogel PatchEsflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen |
| Control Drug | Placebo comparator | Drug: Esflurbiprofen Hydrogel PatchPlacebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- acute sports-related soft-tissue injury/contusion (strains, sprains, bruises) of the upper or lower limb
- location of injury such that pain-on-movement (POM) is elicited on by specified exercises
- enrollment within 6 hours of the injury
- baseline VAS score for POM of injured extremity > 50 mm on a 100 mm VAS
- size of injury, as assessed by investigator, ≥ 25 cm2 and ≤ 120 cm2
Key exclusion criteria (15 listed)
- significant concomitant injury in association with the index acute sports-related soft- tissue injury/contusion; e.g. fracture, nerve injury, ligament disruption, tear of muscle or cartilage, or open wound
- excessively hairy skin at application site, cutting the hair in the injured site prior to patch application will qualify for inclusion
- current skin disorder or shaving hair at application site
- history of excessive sweating/hyperhidrosis inclusive of application site
- intake of NSAIDs or analgesics within 36 hours, opioids within 7 days, or corticosteroids within 60 days of inclusion in the study
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 PatchEsflurbiprofen is a cyclooxygenase (COX) inhibitor | Drug | Active Arm, Control Drug |
Primary outcome
Change of Pain-on-movement (POM) Compared to Baseline
Time frame: Change from baseline to Visit 5 (72 hours after initiating treatment)
Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
13 secondary outcomes
Pain-on-movement (POM) on VAS
Time frame: Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment
Area-under-the-curve for POM on VAS
Time frame: Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment
Pain-at-rest on VAS
Time frame: Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatment
Time to Meaningful and Optimal Reduction
Time frame: Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment
Time to Complete Resolution of Pain
Time frame: Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatment
Responder Rate 1
Time frame: 72 hours
Global Efficacy Assessments 1 by Patient
Time frame: 48 h, 72 h, and 168 h
Global Efficacy Assessments 2 by Patient
Time frame: 48 h, 72 h, and 168 h
Global Efficacy Assessments 1 by Investigator
Time frame: 48 h, 72 h, and 168 h
Use of Rescue Medication
Time frame: 0-168h
Resolution of Soft Tissue Injury/Contusion
Time frame: 168h
SPID of POM VAS Changes
Time frame: 0-24 h, 0-48 h, 0-72 h, and 0-96 h
Responder Rate 2 at 168h
Time frame: 168h
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Hiroshi Aoki study chair
Teikoku Seiyaku Co., Ltd.
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 Soft Tissue Injuries and Contusions, run by Teikoku Seiyaku Co., Ltd. at 1 site in Germany.
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 9 inclusion and 15 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 28 Sep 2023. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 28 Sep 2023). 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?
Change of Pain-on-movement (POM) Compared to Baseline (time frame: Change from baseline to Visit 5 (72 hours after initiating treatment)). 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 28 Sep 2023.